| Zepsun (donafenib) / Suzhou Zelgen |
ChiCTR2100054041: Efficacy and safety of donafenib combined with TACE or HAIC in the treatment of hepatocellular carcinoma |
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| Recruiting | 4 | 50 | | No | Shandong Cancer Hospital; Shandong Cancer Hospital, self-funded | Hepatocellular carcinoma | | | | |
ChiCTR2100053712: Clinical study of the efficacy and safety of donafenib plus S-1 in first-line treatment of metastatic pancreatic cancer that failed NG(nab-Paclitaxel plus Gemcitabine) regimen |
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| Recruiting | 4 | 10 | | Donafenib, Teggio | Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, self-funded | pancreatic cancer | | | | |
NCT05022628: Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis |
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| Not yet recruiting | 4 | 30 | NA | Donafenib, Radiotherapy | Anhui Provincial Hospital | HCC, Chemotherapy Effect | 08/23 | 08/24 | | |
ChiCTR2100050061: Clinical study on the safety and efficacy of donafenib tosylate combined with camrelizumab in the first-line/second-line treatment of patients with advanced hepatocellular carcinoma |
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| Not yet recruiting | 4 | 36 | | Donafenib Tosylate Tablets Combined with Camrelizumab ;Donafenib Tosylate Tablets Combined with Camrelizumab | Peking Union Medical College Hospital; Chinese Academy of Medical Sciences Peking Union Medical College Hospital, self-raised | Hepatocellular carcinoma | | | | |
ChiCTR2100050060: Clinical study on the safety and efficacy of donafenib tosylate combined with toripalimab injection in first-line/second-line treatment of patients with advanced biliary tract cancer who refuse chemotherapy |
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| Not yet recruiting | 4 | 36 | China | Donafenib tablet, 200 mg BID Po; Toripalimab, 240 mg Q3W IV ;Donafenib tablet, 200 mg BID Po; Toripalimab, 240 mg Q3W IV | Peking Union Medical College Hospital, Chinese Academy of Medical Sciences ; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, self-raised | Biliary tract cancer | | | | |
ChiCTR2100052129: A single-arm, open-ended study on the efficacy and safety of donafenib combined with temozolomide and radiotherapy in the treatment of postoperative patients with high-grade glioma |
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| Not yet recruiting | 4 | 10 | | Donafenib, 200 mg BID po; temozolomide, 75 mg/m2·d; concurrent radiotherapy | The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University, self-raised | Hepatocellular carcinoma | | | | |
ChiCTR2200057124: Clinical study on the efficacy and safety of donafenib toluenesulfate tablets combined with TACE in the treatment of early and middle stage hepatocellular carcinoma not suitable for surgical resection |
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| Not yet recruiting | 4 | 38 | | Donafenib combined with TACE | Beijing You'an Hospital, Capital Medical University; Beijing You'an Hospital, Capital Medical University, self-funded | Hepatocellular carcinoma | | | | |
ChiCTR2200056206: Hepatic Arterial Infusion Chemotherapy (HAIC) combined with Donafenib and Sintilimab in the treatment of patients with unresectable hepatocellular carcinoma: a single-arm, exploratory clinical study |
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| Not yet recruiting | 4 | 41 | | HAIC and Donafinil 0.1g, bid and Sintilimab 200mg, Q3w | Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology; Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology, self-raised | Hepatocellular carcinoma | | | | |
ChiCTR2200058747: Efficacy and safety of Donafenib combined with camrelizumab + TACE in the first-line treatment of advanced HCC |
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| Not yet recruiting | 4 | 30 | | Donafenib combined with camrelizumab + TACE | Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Suzhou Zelgen Biopharmaceuticals Co.,Ltd. | Hepatocellular Carcinoma | | | | |
ChiCTR2200059297: The safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) + donafenib + PD-1 antibody in the conversion-resection of advanced unresectable hepatocellular carcinoma: Observational Real World Study. |
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| Not yet recruiting | 4 | 30 | | Nil | The Fifth Medical Center of PLA General Hospital; The Fifth Medical Center of PLA General Hospital, Self-fund | Hepatocellular carcinoma | | | | |
NCT05673824: Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies. |
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| Recruiting | 4 | 53 | RoW | Huaier Granule, VEGFR-TKIs | Fudan University, LinkDoc Technology (Beijing) Co. Ltd. | Nephrotoxicity | 02/25 | 04/25 | | |
ChiCTR2100050053: The efficacy and safety of Donafenib combined with TACE in the treatment of advanced hepatocellular carcinoma |
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| Not yet recruiting | 4 | 30 | | donafeinib+TACE | Beijing Friendship Hospital, Capital Medical University; Beijing Friendship Hospital, Capital Medical University, self-financed | Hepatocellular carcinoma | | | | |
NCT06496815: Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy |
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| Not yet recruiting | 4 | 32 | NA | Donafenib, transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy, PD-1,PD-L1 | Tongji Hospital | Unresectable Hepatocellular Carcinoma | 08/26 | 07/27 | | |
ChiCTR2100049493: Donafenib and Toripalimab in combination with transarterial chemoembolization and bronchial arterial chemoinfusion Versus Donafenib and Toripalimab in the treatment of hepatocellular carcinoma with pulmonary metastasis: a randomized controlled trial |
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| Not yet recruiting | 4 | 130 | China | TACE、BAI combined with donafinib and triprizumab ;donafinib and triprizumab | Department of Interventional Radiology, Chinese People’s Liberation Army General Hospital ; Department of Interventional Radiology, Chinese People’s Liberation Army General Hospital, self-funded | Hepatocellular carcinoma | | | | |
ChiCTR2100050662: A single-arm, open-label clinical study of donafenib combined with sintilimab for unresectable hepatocellular carcinoma |
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| Not yet recruiting | 4 | 30 | | Donafinil and Sintilimab | The First Affiliated Hospital of Guangxi Medical University; The First Affiliated Hospital of Guangxi Medical University, self-funded | Hepatocellular carcinoma | | | | |
ChiCTR2100051171: Safety and efficacy of Donafenib combined with PD -1/PD-L1 inhibitors in primary/second-line treatment of patients with advanced hepatocellular carcinoma |
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| Recruiting | 4 | 50 | | combination of anti-pd-1 / pd-l1 antibody and Donafenib ;combination of anti-pd-1 / pd-l1 antibody and Donafenib | Department of Hepatobiliary Surgery Chinese PLA General Hospital & Medical School; Chinese PLA General Hospital & Medical School, self-funded | Hepatocellular carcinoma | | | | |
ChiCTR2200063822: A Multicenter Registration Study to Evaluate the Efficacy and Safety of Donafenib as 1st line treatment in patients with unresectable HCC |
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| Not yet recruiting | 4 | 200 | | Donafenib | Sun Yat-sen memorial hospital Sun Yat-sen university; Sun Yat-sen memorial hospital Sun Yat-sen university, self-raised funds | hepatocellular carcinoma | | | | |
HOPE-a, ChiCTR2200064030: A Multicenter Registration Study to Evaluate the Efficacy and Safety of Donafenib in Patients with HCC as Adjuvant Treatments for Hepatocellular Carcinoma After Radical Resection |
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| Recruiting | 4 | 200 | | Donafenib | Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, self-raised | hepatocellular carcinoma | | | | |
ChiCTR2100052000: Clinical study on the efficacy and safety of donafenib toluenesulfonic tablets combined with argon and helium cryoablation and camrelizumab injection in the treatment of middle and advanced hepatocellular carcinoma unsuitable for surgery |
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| Not yet recruiting | 4 | 30 | | Donafenib toluenesulfonic tablets, 200 mg BID po; camrelizumab, 3 mg/kg Q3W iv; cryoablation | The Fifth Medical Centre of the General Hospital of PLA; The Fifth Medical Centre of the General Hospital of PLA, self-raised | Hepatocellular carcinoma | | | | |
ChiCTR2200059858: A single arm, real world stuy for the effectiveness and safety of HAIC combined with Donafenib Toslate Tablets and Sindilimab Injection in the prophylactic treatment of MVI positive patients‘ recurrence after radical resection of hepatocelluar carcinoma |
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| Not yet recruiting | 4 | 30 | | HAIC combined with Donafenib Toslate Tablets and Sindilimab Injection | The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University, Self-raised | Hepatocelluar carcinoma | | | | |
ChiCTR2300075973: The Efficacy and Safety of Donafenib in Neoadjuvant Treatment of Locally Advanced Thyroid Cancer: a Phase II Clinical Trial |
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| Not yet recruiting | 4 | 13 | | donafenib | Fujian Cancer Hospital; Fujian Cancer Hospital, Self-fund | differentiated thyroid cancer | | | | |
ChiCTR2300074183: Neoadjuvant donafenib and anti-PD-1antibody ± hepatic arterial infusion chemotherapy for resectable hepatocellular carcinoma with high recurrence risks: real-world research |
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| Not yet recruiting | 4 | 104 | | donafenib＋PD-1±HAIC for perioperative period (preoperative neoadjuvant + postoperative adjuvant); donafenib＋PD-1 for postoperative adjuvant | The General Hospital of the People's Liberation Army; The General Hospital of the People's Liberation Army, self-fund | Hepatocellular carcinoma | | | | |
ChiCTR2300076242: Canceled by the investigator. Clinical study on the first-line treatment of advanced hepatocellular carcinoma with B-grade liver function using lenvatinib combined with sintilimab and compared to donafenib combined with sintilimab |
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| Not yet recruiting | 3 | 148 | | lenvatinib combined with sintilimab; Donafenib combined with sintilimab | Beijing Ditan Hospital, Capital Medical University; Beijing Ditan Hospital, Capital Medical University, investigator initiated trial (IIT) | hepatocellular carcinoma | | | | |
Neo-TACE, NCT05171166: Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial. |
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| Recruiting | 2/3 | 156 | RoW | HAIC, TACE, FOLFOX, oxaliplatin, leucovorin, 5-fluorouracil, cTACE or DEB-TACE, EPI, Donafenib, Dona | Peking University | Hepatocellular Carcinoma | 06/24 | 12/24 | | |
NCT06482086: Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer |
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| Recruiting | 2 | 75 | RoW | Anlotinib, Lenvatinib, Sorafenib, Donafenib, Everolimus, Apatinib, Dabrafenib + Trametinib, Cabozantinib, Vandetanib, Entrectinib, Pralsetinib, Larotrectinib | West China Hospital | Locally Advanced Thyroid Gland Carcinoma | 12/24 | 12/25 | | |
FRONT-2, NCT06232759: TACE Combined With Tyrosine Kinase Inhibitors and Tislelizumab in Unresectable Hepatocellular Carcinoma |
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| Completed | 2 | 56 | RoW | Transarterial chemoembolization combined with Tyrosine Kinase Inhibitors and Tislelizumab | Guangxi Medical University | Hepatocellular Carcinoma | 10/23 | 01/24 | | |
NCT05350943: HAIC Combined With Toripalimab and Donafenib for Advanced BTC |
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| Enrolling by invitation | 2 | 70 | RoW | HAIC, Gemcitabine, Oxaliplatin, Toripalimab, Donafenib | Lu Wang, MD, PhD | Biliary Tract Adenocarcinoma | 11/22 | 11/23 | | |
| Recruiting | 2 | 30 | RoW | Donafenib+sintilimab | Second Affiliated Hospital of Guangzhou Medical University | Hepatocellular Carcinoma | 05/23 | 05/23 | | |
NCT05138159: A Study of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen |
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| Not yet recruiting | 2 | 10 | RoW | Donafenib, S1 | Fudan University | Metastatic Pancreatic Cancer | 05/23 | 07/23 | | |
NCT05348811: HAIC Combined With Donafenib and Sintilimab for Unresectable ICC |
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| Recruiting | 2 | 32 | RoW | HAIC combined with donafenib and sintilimab, HAIC-donafenib-sintilimab | Zhongda Hospital | Cholangiocarcinoma | 06/23 | 07/23 | | |
NCT05493332: HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC |
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| Not yet recruiting | 2 | 93 | NA | HAIC(FOLFOX), Hepatic Artery Infusion Chemotherapy, FOLFOX, Oxaliplatin, Leucovorin, Fluorouracil, Toripalimab, Donafenib | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Hepatocellular Carcinoma | 09/23 | 09/24 | | |
ChiCTR2100051714: HAIC combined with donafenib and camrelizumab in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus (PVTT) invasion into the main portal vein: a single-arm, exploratory clinical study |
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| Not yet recruiting | 2 | 32 | | HAIC(hepatic arterial infusion chemotherapy), donafinil and carrelizumab | The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University, Suzhou Zelgen Biopharmaceuticals Co., Ltd. | Hepatocellular carcinoma | | | | |
NCT05545124: Study of Donafenib Combined With Tislelizumab in the Adjuvant Treatment of Primary HCC With High Risk of Recurrence |
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| Not yet recruiting | 2 | 32 | NA | Donafenib + Tislelizumab | Henan Cancer Hospital | Hepatocellular Carcinoma | 11/23 | 11/24 | | |
ChiCTR2100044790: A Clinical Study of the Effcacy and Safety of Donafenib Combined with Toripalimab in the Second-Line Treatment of Patients with Extensive-stage Small Cell Lung Cancer |
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| Recruiting | 2 | 61 | China | Donafenib Combined with Toripalimab; Donafenib Combined with Toripalimab | Chinese PLA General Hospital ; Chinese PLA General Hospital, self funded | SCLC | | | | |
DoHAICs, NCT05166772: Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）in the First-line Treatment of Unresectable Hepatocellular Carcinoma |
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| Not yet recruiting | 2 | 30 | NA | Donafenib, Sintilimab, HAIC | Tianjin Medical University Cancer Institute and Hospital | Hepatocellular Carcinoma | 12/23 | 12/24 | | |
NCT05161143: Donafenib Combined With TACE as Adjuvant Therapy of Patients With Hepatocellular Carcinoma |
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| Not yet recruiting | 2 | 30 | RoW | Donafenib, TACE | Peking Union Medical College Hospital, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Hepatocellular Carcinoma | 12/23 | 12/24 | | |
| Recruiting | 2 | 20 | RoW | Donafenib combined with paclitaxel and platinum ± PD-1 antibody | Lei Li | Targeted Therapy, Chemotherapy, Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Survival Outcomes, Adverse Effect | 12/23 | 06/24 | | |
NCT06244225: HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma |
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| Recruiting | 2 | 38 | RoW | Donafenib； Sintilimab； HAIC | Wuhan Union Hospital, China | Hepatocellular Carcinoma | 01/26 | 01/28 | | |
NCT04962958: Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery |
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| Not yet recruiting | 2 | 30 | RoW | Hepatic arterial infusion chemotherapy, HAIC, Folfox Protocol, Oxaliplatin , fluorouracil, and leucovorin, Donafenib | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Huashan Hospital, The Second Affiliated Hospital of Harbin Medical University | Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasms, Digestive System Neoplasms, Antineoplastic Agents, Donafenib, Fluorouracil, Oxaliplatin, Antimetabolites | 03/24 | 08/24 | | |
NCT05262959: A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC |
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| Completed | 2 | 30 | RoW | Donafenib, PD-1, TACE | Shanghai Zhongshan Hospital | Donafenib | 04/24 | 05/24 | | |
ChiCTR2100045770: Prospective, single-arm, multicenter, open phase II study of hepatic arterial infusion chemotherapy combined with donafenib toluenesulfonic acid in adjuvant treatment of hepatocellular carcinoma patients with high risk factors for recurrence after hepatectomy |
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| Recruiting | 2 | 30 | | hepatic artery infusion chemotherapy with donafenib | Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Self-financed | Hepatocellular carcinoma | | | | |
NCT06498622: Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab |
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| Recruiting | 2 | 45 | RoW | Donafenib + Envafolimab | Anhui Provincial Hospital | Hepatocellular Carcinoma | 05/27 | 05/27 | | |
NCT06512467: Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma |
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| Not yet recruiting | 2 | 30 | NA | Donafenib, Sintilimab, HAIC | Tianjin Medical University Cancer Institute and Hospital | Hepatocellular Carcinoma | 07/26 | 12/26 | | |
ChiCTR2100048460: A prospective, single arm, open phase II study of donafenib as adjuvant therapy after radical hepatectomy for hepatocellular carcinoma |
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| Not yet recruiting | 2 | 61 | | Donafenib | Hu'nan Provincial Tumor Hospital; Hu'nan Provincial Tumor Hospital, self-funded | Hepatocellular carcinoma | | | | |
NCT05668884: GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma |
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| Recruiting | 2 | 93 | RoW | Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab | Fudan University | Biliary Tract Carcinoma | 09/26 | 03/27 | | |
NCT05576909: Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation |
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| Recruiting | 2 | 20 | RoW | Donafenib, TACE | Beijing Tsinghua Chang Gung Hospital, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Hepatocellular Carcinoma | 10/24 | 10/25 | | |
ChiCTR2100050505: Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma |
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| Recruiting | 2 | 48 | | Donafenib plus Sintilimab in combination with transarterial chemoembolisation | Nanfang Hospital, Southern Medical University; Nanfang Hospital, Southern Medical University, Self-funded | hepatocellular carcinoma | | | | |
NCT05507632: Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma |
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| Not yet recruiting | 2 | 48 | NA | Donafenib plus Sintilimab in combination with transarterial chemoembolisation | Nanfang Hospital of Southern Medical University | Unresectable Hepatocellular Carcinoma | 12/24 | 12/26 | | |
ChiCTR2300073728: Efficacy and safety of perioperative treatment of donafenib combined with tislelizumab in resectable hepatocellular carcinoma (HCC) |
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| Not yet recruiting | 2 | 78 | China | Preoperation (neoadjuvant): donafenib (100 mg Bid, oral), tislelizumab (200 mg, Q3W, intravenous infusion) for 2 cycles; Surgery; Postoperation (adjuvant): donafenib (100 mg Bid, oral) combined with tislelizumab (200 mg,Q3W, intravenous infusion) for six months | Third Affiliated Hospital of Naval Medical University; Third Affiliated Hospital of Naval Medical University, self-funded | HCC | | | | |
ChiCTR2300077787: A single arm, efficacy and safety study of Donafenib combined with cardunilimab in the treatment of advanced HCC |
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| Recruiting | 2 | 29 | | donafenib combined with cardunilimab | The Sixth Affiliated Hospital of Sun Yat-sen University; The Sixth Affiliated Hospital of Sun Yat-sen University, Research Group of Weidong Pan | Hepatocellular carcinoma | | | | |
ChiCTR2400082386: Transarterial chemoembolization (TACE) and Stereotactic body radiation therapy (SBRT) Combined with TKIs and Sintilimab for Advanced Hepatocellular Carcinoma with Portal Vein Tumor Thrombosis: A Single-Arm, Prospective, Phase II Clinical Study |
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| Recruiting | 2 | 256 | | Transarterial chemoembolization (TACE):The interval between the TACE and radiation therapy is 4-6 weeks, and the TKIs should be suspended during the perioperative period (7 days) of TACE. TACE will be repeated less than 4 times, which is determined by interventional radiologist.; Stereotactic body radiation therapy (SBRT): patients will receive SBRT within 7 days after the initiation of systemic therapies.; tyrosine kinase inhibitors (TKIs): patients will receive sorafenib (0.4g po bid) , or donafenib (0.2g po bid), or lenvatinib (12mg po qd (body weight ≥ 60kg); 8mg po qd (body weight <60 kg)). Treatment would be terminated if there was disease progression or unacceptable toxicity during treatment.; Patients received 200 mg of sintilimab intravenously over 60 min every 3 weeks. Treatment would be terminated if there was disease progression or unacceptable toxicity during treatment. | West China Hospital, Sichuan University; West China Hospital, Sichuan University, No founding | hepatocellular carcinoma | | | | |
NCT02698111: Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma |
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| Terminated | 1/2 | 20 | RoW | Donafenib, CM4307 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Nasopharyngeal Carcinoma | 10/21 | 10/21 | | |
NCT04979663: GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer |
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| Recruiting | 1/2 | 10 | RoW | Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab | Fudan University | Biliary Tract Carcinoma | 06/22 | 06/22 | | |
ChiCTR2100048891: Study of the safety and efficacy of donafenib combined with toripalimab in patients with non-MSI-H metastatic colorectal cancer |
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| Not yet recruiting | 1/2 | 35 | China | Donafenib + Toripalimab | Sichuan Cancer Hospital ; Sichuan Cancer Hospital, Suzhou Zelgen Biopharmaceuticals Co., Ltd. | colorectal cancer | | | | |
NCT04503902: Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma |
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| Recruiting | 1/2 | 46 | RoW | Donafenib Tosilate Tablets, Donafenib, Toripalimab Injection, JS001 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Advanced Hepatocellular Carcinoma | 12/23 | 12/23 | | |
NCT04612712: A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors |
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| Recruiting | 1/2 | 42 | RoW | Donafenib Tosilate Tablets, KN046 Injection | Suzhou Zelgen Biopharmaceuticals Co.,Ltd, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Advanced Gastrointestinal Tumors | 12/23 | 12/23 | | |
NCT06239298: A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor |
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| Recruiting | 1/2 | 130 | RoW | ZG005 Powder for Injection, ZG005, Donafenib Tosilate Tablets, Donafenib | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Solid Tumor | 03/26 | 05/26 | | |
ChiCTR2100051537: Efficacy and safety of large fractionated radiotherapy sequential sintilimab combined with donafenib in the treatment of hepatocellular carcinoma complicated with portal vein tumor thrombus: a phase I/II study |
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| Not yet recruiting | 1/2 | 43 | | Radiotherapy: 3Gy x 10-15F，then Donafenib 0.1g or 0.2g qd+sintilimab 200mg d1, Q3W | The Second Affiliated Hospital of Chongqing Medical University; The Second Affiliated Hospital of Chongqing Medical University, Suzhou Zelgen Biopharmaceuticals Co., Ltd. | Primary hepatocellular carcinoma | | | | |
NCT02489201: A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer |
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| Terminated | 1b | 19 | RoW | donafenib tosilate tablets, CM4307 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Oesophageal Cancer | 10/20 | 10/20 | | |
NCT04472858: A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors |
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| Recruiting | 1 | 30 | RoW | Donafenib, CS1001 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd, CStone Pharmaceuticals | Advanced Solid Tumor | 12/23 | 12/23 | | |
NCT04605185: Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma |
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| Active, not recruiting | 1 | 18 | RoW | Donafenib Tosilate Tablets, Toripalimab Injection, JS001 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unresectable Hepatocellular Carcinoma | 12/24 | 12/24 | | |
PATH, NCT04418401: Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients |
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| Recruiting | 1 | 30 | RoW | Donafenib and anti-PD-1 antibody | Zhejiang University | Hepatocellular Carcinoma | 12/23 | 06/24 | | |
NCT06363006: Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer |
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| Recruiting | 1 | 40 | RoW | TKI+Cardunilimab | Peking Union Medical College Hospital | Hepatocellular Carcinoma | 01/26 | 01/27 | | |
ChiCTR2400082372: The efficacy and safety of GC in combination with tislelizumab and donafenib in the treatment of potentially resectable locally advanced biliary tract tumors: a single-arm, prospective, exploratory study. |
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| Not yet recruiting | 1 | 20 | | Gemcitabine 1000mg/m2, cisplatin 25mg/m2, D1,8, Q3W + donafenib 200mg bid, continuous taking + tislelizub 200mg, Q3W chemotherapy for up to 8 cycles, if still inoperable, switch to donafenib combined with tislelizumab maintenance therapy. | West China Hospital of Sichuan University; West China Hospital of Sichuan University, Funding for the clinical research project of West China Hospital, Sichuan University | Biliary tract tumors | | | | |
| Completed | N/A | 279 | RoW | Transarterial chemoembolization, TACE, Systemic treatment | Zhejiang University | Hepatocellular Carcinoma | 03/23 | 10/23 | | |
ChiCTR1800017112: Randomized, open-label, 4-way reference replicated crossover bioequivalence study of donafenib 100 mg tablet (producted by Zelgen versus WuXi AppTec) in healthy subjects under fasting conditions |
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| Recruiting | N/A | 56 | | 1 tablet of IP taken per period, total 2 periods ;1 tablet of IP taken per period, total 2 periods | Jilin University First Hospital; Jilin University First Hospital, Suzhou Zelgen Biopharmaceuticals Co., Ltd | health subjects | | | | |
NCT05247996: TACE Combined With "Target Immune" Therapy for First-line Treatment in the Treatment of Intrahepatic Cholangiocarcinoma |
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| Not yet recruiting | N/A | 98 | NA | Transcatheter arterial chemoembolization, TACE Thrapy, Multi-target Drug Therapy, Target Therapy, Immunocheckpoint Inhibitor Therapy, Immune Therapy, Systemic Intravenous Chemotherapy, Traditional Chemotherapy | The Central Hospital of Lishui City | Intrahepatic Cholangiocarcinoma | 12/22 | 12/23 | | |
| Recruiting | N/A | 474 | RoW | PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, TACE | Zhongda Hospital | Hepatocellular Carcinoma | 08/23 | 08/23 | | |
CHANCE2202, NCT05332496: TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate HCC |
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| Recruiting | N/A | 220 | RoW | PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, TACE | Zhongda Hospital | Hepatocellular Carcinoma | 08/23 | 09/23 | | |
ChiCTR2200065637: Efficacy and Safety of the Combination of transarterial therapies with donafenib plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma: A Retrospective Real-world study |
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| Not yet recruiting | N/A | 50 | | transarterial therapiescombined with donafenib and Anti-PD-1 Antibody | Zhujiang Hospital of Southern Medical University; Zhujiang Hospital of Southern Medical University, self-raised funds | hepatocellular carcinoma | | | | |
| Recruiting | N/A | 300 | RoW | TACE, transarterial chemoembolization, Lenvatinib, levima, Anti-PD-1 monoclonal antibody, PD-1 inhibitor, Bevacizumab Biosimilar IBI305 plus sintilimab, Byvasda (B) plus S, Bevacizumab plus Atezolizumab, Avastin plus Tecentriq, apatinib plus camrelizumab, Apa plus C, Sorafenib, Nexavar, Donafenib, Zepsun, Regorafenib, stivarga | Tongji Hospital, Chinese Cooperative Group of Liver Cancer, Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province, The Second Affiliated Hospital of Fujian Medical University, Geneplus-Beijing Co. Ltd., Haplox Biotechnology Co., Ltd. | Hepatocellular Carcinoma Non-resectable | 12/23 | 12/24 | | |
ChiCTR2100053861: Clinical study of donafenib tosylate combined with sintilimab and AG regimen in the treatment of stage II-III unresectable intrahepatic cholangiocarcinoma |
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| Recruiting | N/A | 30 | | Donafenib Tosylate Tablets Combined with Sintilimab and AG Regimen | Subei People's Hospital; Subei People's Hospital, self-financed | Intrahepatic cholangiocarcinoma | | | | |
ZG005-IIT-001, NCT06233994: A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma |
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| Not yet recruiting | N/A | 30 | RoW | ZG005 Powder for Injection, ZG005, Donafenib Tosilate Tablets, Donafenib, Bevacizumab | Changsha Taihe Hospital | Advanced Hepatocellular Carcinoma | 01/26 | 01/26 | | |
NCT05200221: A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma in Routine Clinical Practice |
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| Recruiting | N/A | 300 | RoW | | Shanghai Zhongshan Hospital | Donafenib, Hepatocellular Carcinoma | 01/24 | 03/24 | | |
NCT05205629: A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC |
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| Recruiting | N/A | 150 | RoW | Donafenib combined with TACE, Donafenib plus TACE | Shanghai Zhongshan Hospital | Hepatocellular Carcinoma, Donafenib | 01/24 | 03/24 | | |
CCGLC-001, NCT05713994: Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma |
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| Recruiting | N/A | 300 | RoW | HAIC, hepatic arterial infusion chemotherapy of FOLFOX, Bevacizumab plus Atezolizumab, Avastin plus Tecentriq, Bevacizumab Biosimilar IBI305 plus sintilimab, Byvasda (B) plus S, Lenvatinib, Lenvima, Sorafenib, Nexavar, Donafenib, Zepsun, Regorafenib, stivarga, apatinib plus camrelizumab, Apa plus C, Anti-PD-1 monoclonal antibody, PD-1 inhibitor | Wan-Guang Zhang, Chinese Cooperative Group of Liver Cancer (CCGLC), Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province, Haplox Biotechnology Co., Ltd., Geneplus-Beijing Co. Ltd., The Second Affiliated Hospital of Fujian Medical University | Hepatocellular Carcinoma Non-resectable | 04/24 | 12/24 | | |
NCT06632106: HAIC in Combination with Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors for Advanced HCC |
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| Active, not recruiting | N/A | 97 | RoW | hepatic artery infusion chemotherapy, Tyrosine kinase inhibitor (TKIs), Immune Checkpoint Inhibitors | First Hospital of China Medical University | Hepatic Arterial Infusion Chemotherapy, Tyrosine Kinase Inhibitor, Immune Checkpoint Inhibitors, Hepatocellular Carcinoma (HCC) | 01/25 | 05/25 | | |
NCT06581315: Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma |
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| Recruiting | N/A | 204 | RoW | Donafenib, Zepsun | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Hepatocellular Carcinoma, Adjuvant Therapy | 08/27 | 08/32 | | |
NCT06609876: Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC |
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| Recruiting | N/A | 108 | RoW | Thermal ablation, Donafenib | Sun Yat-sen University, Chinese PLA General Hospital | Hepatocellular Carcinoma, Microwave Ablation, Donafenib, Recurrent Tumor | 10/26 | 10/28 | | |
ChiCTR2200061063: Clinical study of oxaliplatin plus raltitrexed hepatic arterial infusion chemotherapy (HAIC) combined with targeted drugs (sorafenib/lenvatinib/donafenib) in the treatment of unresectable patients with recurrent hepatocellular carcinoma after liver transplantation |
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| Recruiting | N/A | 66 | | HAIC plus targeted therapy ;Only targeted therapy | The Fifth Affiliated Hospital of Sun Yat-Sen University; The Fifth Affiliated Hospital of Sun Yat-Sen University, self-raised | Hepatocellular carcinoma | | | | |
ChiCTR2200063003: Efficacy and safety of donafenib combined with tislelizumab and TACE for adjuvant therapy in patients with hepatocellular carcinoma after surgery: a single-arm, prospective, exploratory study |
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| Not yet recruiting | N/A | 32 | China | Subjects receive TACE treatment once in the first month after surgery, with tislelizumab 200 mg i.v. q3w (day 1 of each 21-day cycle), and donafenib 200 mg p.o. bid). | West China Hospital of Sichuan University ; West China Hospital of Sichuan University, Horizontal project funded by Suzhou Zejing Biopharmaceutical Co., Ltd. | Hepatocellular Carcinoma | | | | |
ChiCTR2300076993: Observational study of the efficacy and safety of Donafenib and sindilizumab in combination with TACE or HAIC for first-line treatment of unresectable hepatocellular carcinoma |
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| Recruiting | N/A | 30 | | Donafenib and Sindillizumab combined with TACE or HAIC | Beijing You'an Hospital, Capital Medical University; Beijing You'an Hospital, Capital Medical University, Optional project | Hepatocellular carcinoma | | | | |
ChiCTR2400081488: An observational study on the efficacy and safety of Donafinib and Sintilimab combined with TACE in first-line treatment of unresectable hepatocellular carcinoma |
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| Not yet recruiting | N/A | 50 | | Donafenib and Sindillizumab combined with TACE | The Affiliated Hospital of Jining Medical University; The Affiliated Hospital of Jining Medical University, Self-raised | Hepatocellular carcinoma | | | | |
NCT05638438: Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study |
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| Not yet recruiting | N/A | 100 | NA | transarterial therapies, donafenib, Anti-PD-1 Antibody | Zhujiang Hospital | Hepatocellular Carcinoma Non-resectable | 06/23 | 09/23 | | |
