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- | Zepsun (donafenib) / Suzhou Zelgen
Journal, Combination therapy, PARP Biomarker, IO biomarker: Donafenib inhibits PARP1 expression and induces DNA damage, in combination with PARP1 inhibitors promotes apoptosis in liver cancer cells. (Pubmed Central) - Sep 11, 2024
These data suggest that the combination of donafenib and a PARP1 inhibitor results in more significant DNA damage in cells and promotes cell apoptosis. Thus, the combination of donafenib and PARP1 inhibitors has the potential to be a treatment option for liver cancer.
- | Zepsun (donafenib) / Suzhou Zelgen, Sotyktu (deucravacitinib) / BMS
Journal: Electrocatalytic reductive deuteration of arenes and heteroarenes. (Pubmed Central) - Sep 1, 2024
Mechanistic investigations suggest that the Ru-D species, generated by electrolysis of D2O in the presence of nitrogen-doped Ru electrode, are key intermediates that directly reduce aromatic compounds. This quick and cost-effective methodology for the preparation of highly D-labeled saturated (hetero)cycles compounds could be applied in the drug development and metabolism studies.
- | Zepsun (donafenib) / Suzhou Zelgen
Journal: Efficacy and safety of hepatic arterial infusion chemotherapy combined with donafenib in the treatment of unresectable hepatocellular carcinoma. (Pubmed Central) - Aug 26, 2024
This quick and cost-effective methodology for the preparation of highly D-labeled saturated (hetero)cycles compounds could be applied in the drug development and metabolism studies. Donafenib combined with HAIC in the treatment of unresectable HCC patients can notably reduce serum AFP levels, improve hepatic fibrosis, enhance short-term efficacy, prolong PFS, and have a favorable safety profile.
- | Tyvyt (sintilimab) / Eli Lilly, Zepsun (donafenib) / Suzhou Zelgen
Journal, PD(L)-1 Biomarker, IO biomarker, Surgery: A Patient With Hepatocellular Carcinoma and Lung Metastasis Successfully Underwent Curative Surgery Following the Downstaging Treatment: A Case Report. (Pubmed Central) - Aug 16, 2024
HCC is extremely heterogeneous, and the response to therapeutics varies among patients. There is a lack of useful biomarkers to predict therapeutic efficacy, which needs further studies.
- || Zepsun (donafenib) / Suzhou Zelgen
Review, Journal: VKH-like uveitis during donafenib therapy for hepatocellular carcinoma: a case report and review of the literature. (Pubmed Central) - Aug 2, 2024
Targeted drugs have been commonly used for cancer treatment in recent years, but challenges of ocular side effects emerged gradually. To optimize patient outcomes, regular ophthalmological follow-ups are essential for those undergoing treatment with targeted therapies like Donafenib.
- | Tevimbra (tislelizumab-jsgr) / BeiGene, Zepsun (donafenib) / Suzhou Zelgen
Journal: Case report: Complete response after transcatheter arterial chemoembolization combined with donafenib plus tislelizumab therapy for hepatocellular carcinoma with main trunk portal vein tumor thrombus in a patient coinfected with HIV and HBV. (Pubmed Central) - Jul 30, 2024
This triple therapy treatment regimen resulted in a clinical complete response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) based on contrast-enhanced computed tomography. We first used TACE combined with donafenib and tislelizumab for HCC patients with main trunk portal vein tumor thrombus and HIV-HBV coinfection and achieved complete response.
- | AiTan (rivoceranib) / HLB Bio Group, Zepsun (donafenib) / Suzhou Zelgen, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Immune effect and prognosis of transcatheter arterial chemoembolization and tyrosine kinase inhibitors therapy in patients with hepatocellular carcinoma. (Pubmed Central) - Jul 29, 2024
TACE, in combination with different TKIs, produces different immune responses. Specifically, TACE combined with donafenib or lenvatinib may induce strong anti-tumor immune responses.
- || Zepsun (donafenib) / Suzhou Zelgen
P2 data, Journal, Checkpoint inhibition: Efficacy and Safety Analysis of Transarterial Chemoembolization Plus Donafenib With or Without Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma: A Prospective, Single-Arm, Single-Center, Phase II Clinical Study. (Pubmed Central) - Jul 1, 2024
TACE plus donafenib reduced the tumor feeding artery diameter in patients with unresectable HCC. The safety profile was good, and a high ORR was achieved.
- | Zepsun (donafenib) / Suzhou Zelgen
Journal, Real-world evidence, Real-world: Adjuvant donafenib for hepatocellular carcinoma patients at high-risk of recurrence after radical resection: a real-world experience. (Pubmed Central) - Jun 17, 2024
Postoperative adjuvant donafenib treatment effectively reduced early recurrence among patients with HCC at high-risk of recurrence, while exhibiting favorable safety and tolerability profile. However, these findings warrant further investigation.
- | Zepsun (donafenib) / Suzhou Zelgen, AiRuiKa (camrelizumab) / HLB Bio Group
Journal: Assessment of safety and efficacy of transarterial chemoembolization combined with camrelizumab and donafenib in patients with hepatocellular carcinoma at BCLC stage C: A study of 20 cases. (Pubmed Central) - May 17, 2024
Median progression-free survival and overall survival were 9 and 14 months, respectively. TACE, camrelizumab, and donafenib combination therapy in Chinese advanced HCC patients show effectiveness in extending survival with low severe AEs incidence.
- Zepsun (donafenib) / Suzhou Zelgen, Stivarga (regorafenib) / Bayer, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Comparative efficacy of systemic sequential regorafenib after TACE combined with first-line targeted drugs (donafenib, sorafenib, or lenvatinib) after treatment failure for advanced hepatocellular carcinoma: A retrospective, single-center, real-world study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6910;
This retrospective, single-center, real-world study demonstrated that when donafenib failed the regorafenib could still improve the prognosis of advanced HCC pts with fewer AEs. The study will continue to focus on overall survival(OS) and whether combined ICIs or not in the 1st-line/ 2nd-line treatment could have a positive effect on OS.
- Zepsun (donafenib) / Suzhou Zelgen
Adjuvant donafenib for patients with hepatocellular carcinoma at high risk of recurrence following radical resection: A multi-center, retrospective study in China. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6457;
Adjuvant donafenib may improve RFS of HCC patients at high risk of recurrence following R0, while exhibiting favorable safety. This finding deserves further exploration.
- Zepsun (donafenib) / Suzhou Zelgen
The efficacy and safety of donafenib combined with transcatheter arterial chemoembolization and anti-PD-1 antibodies as first-line therapy for hepatocellular carcinoma: A retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5387;
Background: In Phase III study (ZGDH3), donafenib showed the survival benefit and better safety compared with sorafenib as the first-line treatment for uHCC. The study indicated that donafenib combined with TACE and anti PD-1 antibodies exhibited encouraging efficacy and favorable safety profile in patients with HCC.
- Zepsun (donafenib) / Suzhou Zelgen
A retrospective study on the efficacy and safety of donafenib combined with transarterial chemoembolization (TACE) and with/without immunotherapy in intermediate-advanced hepatocellular carcinoma (HCC). () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5381;
The study indicated that donafenib combined with TACE and anti PD-1 antibodies exhibited encouraging efficacy and favorable safety profile in patients with HCC. Donafenib combined with TACE and with/without immunotherapy showed manageable safety and promising efficacy in intermediate-advanced HCC patients.
- Zepsun (donafenib) / Suzhou Zelgen
TACE-HAIC combined with donafenib and immunotherapy for hepatocellular carcinoma (HCC) with portal vein tumour thrombus (PVTT): A retrospective analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5380;
Of 106 patients included in the analysis, all of them received first-line treatment of TACE (embolization of pirarubicin hydrochloride 40mg, iodized oil 10-20ml with or without gelatin sponge) plus HAIC (oxaliplatin 85 mg/m2 2h, leucovorin 400 mg/m2 1h, fluorouracil bolus 400 mg/m2 in the first 10 minutes, and fluorouracil infusion 2400 mg/m2 for 46h) combined with donafenib 200mg bid, anti-PD-1 antibody Q3W. TACE-HAIC combined with Donafenib and immunotherapy are effective and tolerable for uHCC patients with PVTT.
- Zepsun (donafenib) / Suzhou Zelgen
Transarterial chemoembolization (TACE) combined with donafenib as first-line therapy for unresectable hepatocellular carcinoma (uHCC): A real-world clinical study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5342;
TACE-HAIC combined with Donafenib and immunotherapy are effective and tolerable for uHCC patients with PVTT. The combination of TACE and Donafenib presented good efficacy and tolerability, which could be potentially used as the first-line treatment of Chinese uHCC patients.
- Zepsun (donafenib) / Suzhou Zelgen
Adjuvant therapy with donafenib plus anti () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5338;
P1
No new safety issues were noticed. Clinical trial information: NCT04418401.
- Zepsun (donafenib) / Suzhou Zelgen, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Comparing the efficacy and safety of TACE combined with donafenib or lenvatinib in the treatment of unresectable hepatocellular carcinoma. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5318;
The efficacy of donafenib and lenvatinib combined with TACE in the treatment of uHCC is equivalent. Furthermore, compared to lenvatinib combined with TACE, donafenib combined with TACE has higher safety.
- Zepsun (donafenib) / Suzhou Zelgen
The efficacy and safety of donafenib-containing regimens as first-line therapy for hepatocellular carcinoma (HCC): A multicenter retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5317;
Furthermore, compared to lenvatinib combined with TACE, donafenib combined with TACE has higher safety. These results preliminarily showed that donafenib-containing treatment regimens exhibited encouraging efficacy and favorable safety profile in patients with HCC.
- Zepsun (donafenib) / Suzhou Zelgen
Efficacy and safety of donafenib as adjuvant therapy for patients with hepatocellular carcinoma undergoing curative resection: A retrospective, multicenter cohort study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5304;
This study represents the largest multicenter investigation of adjuvant therapy with donafenib to date, and the findings indicate that donafenib has the potential to be an effective treatment option for preventing postoperative recurrence in HCC. Furthermore, the preoperative AFP ?400ng/mL can serve as an effective biomarker for postoperative administration of donafenib in HCC patients.
- Stivarga (regorafenib) / Bayer
Efficacy and safety of regorafenib plus ICIs as second-line treatment in advanced HCC post-frontline treatment failure: A real-world study from a single center. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5294;
8% of patients, sorafenib plus ICIs in three patients, apatinib plus ICIs, donafenib plus ICIs, and bevacizumab plus ICIs each in one patient... Regorafenib with ICIs is a promising and tolerable second-line treatment for advanced HCC after initial therapy failure.
- Zepsun (donafenib) / Suzhou Zelgen
Efficacy and safety of donafenib combined with anti-PD-1 antibodies for initially unresectable hepatocellular carcinoma (HCC): A retrospective real-world study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5286;
Regorafenib with ICIs is a promising and tolerable second-line treatment for advanced HCC after initial therapy failure. Donafenib combined with anti-PD-1 antibodies shows promising efficacy and manageable toxicity in patients with initially uHCC.
- Zepsun (donafenib) / Suzhou Zelgen
Postoperative adjuvant hepatic arterial infusion chemotherapy combined with donafenib in hepatocellular carcinoma with solitary large tumor and microvascular invasion: A multicenter, prospective, single-arm, phase II trial. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5284;
P2
5 cm and MVI. Clinical trial information: NCT04962958.
- Zepsun (donafenib) / Suzhou Zelgen, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Transarterial chemoembolization combined with donafenib or lenvatinib as first-line treatment for unresectable hepatocellular carcinoma: A single-center real-world retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5274;
DON-TACE and LEN-TACE showed comparable efficacy as first-line therapies for uHCC patients. DON-TACE demonstrated a lower incidence of severe adverse events.
- Zepsun (donafenib) / Suzhou Zelgen
Efficacy and safety of transarterial therapy combined with donafenib plus immune checkpoint inhibitors for unresectable hepatocellular carcinoma: A multicenter retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5271;
This retrospective real-world study showed that transarterial therapy combined with donafenib plus ICIs in the treatment of uHCC patients was well tolerated and comparable clinical efficacy to other triple therapies. This combination strategy may be an appropriate treatment option for uHCC patients.
- Zepsun (donafenib) / Suzhou Zelgen
Efficacy and safety analysis of donafenib combined with transarterial chemoembolization in the treatment of unresectable hepatocellular carcinoma: A prospective, single-arm, single center, phase II clinical study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5268;
TACE combined with donafenib could reduce the tumor feeding artery diameter, which had a good safety profile and a high objective response rate in patients with unresectable HCC. Clinical trial information: ChiCTR2100054041.
- Zepsun (donafenib) / Suzhou Zelgen
Use of integrated multi-omics analysis to determine antitumor efficacy of donafenib in combination with FADS2 inhibition in hepatocellular carcinoma. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4739;
This study employed an extensive multi-omics approach complemented by a range of both in vitro and in vivo experiments. It revealed that the synergistic use of Donafenib and SC-26196 markedly enhances Donafenib-induced the inhibition of cancer cell growth and metastasis, demonstrating a significant synergistic antitumor effect.
- Zepsun (donafenib) / Suzhou Zelgen, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Stereotactic body radiotherapy (SBRT) combined with transcatheter arterial chemoembolization (TACE) and tyrosine kinase inhibitors (TKIs) versus TACE and TKIs alone for unresectable hepatocellular carcinoma (uHCC) with portal vein tumor thrombus (PVTT): A randomized controlled trial. (Hall A; Poster Bd #: 82) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3833;
TKIs (sorafenib 0.4g bid; donafenib 0.2g bid; or lenvatinib 8mg/12mg qd, depending on body weight) were paused during the perioperative period of TACE (up to 4 times). In uHCC patients with PVTT, the combination of SBRT and TACE-TKIs showed significant survival benefit without the identification of any severe safety concerns.
- | Zepsun (donafenib) / Suzhou Zelgen, Stivarga (regorafenib) / Bayer
New P1 trial, Real-world evidence, Real-world, Metastases: Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer (clinicaltrials.gov) - Apr 12, 2024
P1, N=40, Recruiting, Sponsor: Peking Union Medical College Hospital
- || Zepsun (donafenib) / Suzhou Zelgen
Enrollment closed, Trial completion date, Trial primary completion date: Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - Mar 6, 2024
P1, N=18, Active, not recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
In uHCC patients with PVTT, the combination of SBRT and TACE-TKIs showed significant survival benefit without the identification of any severe safety concerns. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- | New trial, Combination therapy, Monotherapy: RSR-HCC-2019-001: Survival Analysis: TACE vs. Combination Therapy in HCC (clinicaltrials.gov) - Feb 15, 2024
P=N/A, N=279, Completed, Sponsor: Zhejiang University
- | Zepsun (donafenib) / Suzhou Zelgen, Avastin (bevacizumab) / Roche
New trial, Combination therapy, Metastases: ZG005-IIT-001: A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - Feb 15, 2024
P=N/A, N=30, Not yet recruiting, Sponsor: Changsha Taihe Hospital
- | Tyvyt (sintilimab) / Innovent Biologics, Zepsun (donafenib) / Suzhou Zelgen
New P2 trial: HAIC (Hepatic Artery Infusion Chemotherapy?HAIC?Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - Feb 15, 2024
P2, N=38, Recruiting, Sponsor: Wuhan Union Hospital, China
- | Tevimbra (tislelizumab-jsgr) / BeiGene
New P2 trial: FRONT-2: TACE Combined With Tyrosine Kinase Inhibitors and Tislelizumab in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - Feb 15, 2024
P2, N=56, Completed, Sponsor: Guangxi Medical University
- | Zepsun (donafenib) / Suzhou Zelgen
Journal: Activation of AMPK pathway by low?dose donafenib and atorvastatin combination improves high?fat diet?induced metabolic dysfunction?associated steatotic liver disease. (Pubmed Central) - Feb 5, 2024
Additionally, donafenib and atorvastatin reduced oxidative stress in the liver tissue and decreased ROS levels. Low?dose donafenib combined with atorvastatin improved MASLD by regulating fatty acid metabolism and reducing oxidative stress through activation of the AMPK signaling pathway.
- |||| ZG005 / Suzhou Zelgen, Zepsun (donafenib) / Suzhou Zelgen
New P1/2 trial, Metastases: A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor (clinicaltrials.gov) - Feb 2, 2024
P1/2, N=130, Not yet recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- | Zepsun (donafenib) / Suzhou Zelgen
Journal, Checkpoint inhibition: Efficacy and Safety of Transarterial Chemoembolization Plus Donafenib with or without Immune Checkpoint Inhibitors as the First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Propensity Score Matching Analysis. (Pubmed Central) - Jan 15, 2024
The incidence of TRAEs in the two groups was similar (P > 0.05). In comparison with TACE plus donafenib, TACE plus donafenib with ICIs could significantly improve DCR, PFS, and OS as a potential first-line treatment for unresectable HCC with an acceptable safety profile.
- | Zepsun (donafenib) / Suzhou Zelgen
Trial primary completion date: Neo-TACE: Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial. (clinicaltrials.gov) - Jan 11, 2024
P2/3, N=156, Recruiting, Sponsor: Peking University
In comparison with TACE plus donafenib, TACE plus donafenib with ICIs could significantly improve DCR, PFS, and OS as a potential first-line treatment for unresectable HCC with an acceptable safety profile. Trial primary completion date: Dec 2023 --> Jun 2024
- | Zepsun (donafenib) / Suzhou Zelgen
Retrospective data, Journal: Transarterial chemoembolization combined donafenib with/without PD-1 for unresectable HCC in a multicenter retrospective study. (Pubmed Central) - Dec 17, 2023
No significant differences were found in the incidence or severity of adverse events between the TACE+DP and TACE+D groups (any grade: 92.9% vs. 94.6%, P=0.270; grade 3 or 4: 33.8% vs. 37.3%, P=0.253). With favorable safety and tolerability, TACE combined with donafenib and PD-1 inhibitors significantly improved PFS, OS, and ORR compared to TACE combined with donafenib.
- tinengotinib (TT-00420) / TransThera Biosci, Tecentriq (atezolizumab) / Roche
Tinengotinib (TT-00420) in combination with atezolizumab in Chinese patients (pts) with biliary tract carcinoma (BTC): Preliminary efficacy and safety results from a phase Ib/II study. (Poster Bd # B18) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_417;
P1/2
Preliminary encouraging efficacy of tinengotinib in combination with atezo was observed in pts with heavily pre-treated BTC. The ongoing study is to further evaluate the safety and efficacy of tinengotinib in combination with atezo in pts with BTC who had prior immunotherapy and/or chemotherapy.
- | Zepsun (donafenib) / Suzhou Zelgen
New P4 trial, Real-world evidence, Real-world: Neoadjuvant donafenib and anti-PD-1antibody (EUDRACT) - Dec 5, 2023
P4, N=104, Not yet recruiting, Sponsor: The General Hospital of the People's Liberation Army; The General Hospital of the People's Liberation Army
The ongoing study is to further evaluate the safety and efficacy of tinengotinib in combination with atezo in pts with BTC who had prior immunotherapy and/or chemotherapy. .
- Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Zepsun (donafenib) / Suzhou Zelgen
Phase classification, Metastases: Study of the safety and efficacy of donafenib combined with toripalimab in patients with non-MSI-H metastatic colorectal cancer (EUDRACT) - Nov 27, 2023
P1/2, N=35, Not yet recruiting, Sponsor: Sichuan Cancer Hospital ; Sichuan Cancer Hospital
. Phase classification: P=N/A --> P1/2
- | Zepsun (donafenib) / Suzhou Zelgen
New P2 trial, Metastases: A single arm, efficacy and safety study of Donafenib combined with cardunilimab in the treatment of advanced HCC (EUDRACT) - Nov 22, 2023
P2, N=29, Recruiting, Sponsor: The Sixth Affiliated Hospital of Sun Yat-sen University
- | Journal: Recent advances in treatment strategies for hepatocellular carcinoma with portal vein cancer thrombus. (Pubmed Central) - Sep 26, 2023
In recent years, the comprehensive treatment of HCC has advanced greatly. This review aims to provide an insight into the treatment modalities available for HCC patients with PVTT.
- | Zepsun (donafenib) / Suzhou Zelgen
Preclinical, Journal: Simultaneous quantification of donafenib, sorafenib, and their N-oxide metabolites in rat plasma using a HPLC-MS/MS method. (Pubmed Central) - Sep 17, 2023
In conclusion, the proposed bioassay was successfully applied to pharmacokinetic studies in rat after administration of donafenib and sorafenib. Our work not only improves the bioanalytical method for determining the plasma concentrations of donafenib, sorafenib, and their N-oxide metabolites, but also provides a scientific reference for clinical pharmacokinetic studies.
- | Zepsun (donafenib) / Suzhou Zelgen, GSKJ4 / Yamagata University
Journal: Donafenib and GSK-J4 Synergistically Induce Ferroptosis in Liver Cancer by Upregulating HMOX1 Expression. (Pubmed Central) - Aug 7, 2023
A chromosome conformation capture assay confirmed that the increased expression of HMOX1 is caused by the significantly enhanced interaction between the promoter and upstream enhancer under dual-drug combination. Taken together, this study elucidates a new synergistic lethal interaction in liver cancer.
- A parametric network meta-analysis of first-line systemic therapies for advanced hepatocellular carcinoma related to overall survival () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2554;
These findings can inform treatment decisions for patients with advanced HCC. However, additional studies are needed to confirm these findings and to evaluate the long-term efficacy and safety of these treatments.
- Tevimbra (tislelizumab) / BeiGene
Efficacy and safety of tislelizumab combined with TKIs and FOLFOX4-HAIC in conversion therapy of unresectable hepatocellular carcinoma () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2546;
Methods Between April, 2021, and March, 2023, we retrospectively analyzed clinical data of patients with uHCC who underwent tislelizumab ,TKIs(Lenvatinib, Donafenib) and FOLFOX4-HAIC...All TRAES were tolerable and manageable. Conclusions Tislelizumab combined with TKIs and FOLFOX4-HAIC showed high conversion rate and acceptable toxicity in the treatment of uHCC, suggesting that this combination could be considered as a new conversion strategy in this population.
- Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Zepsun (donafenib) / Suzhou Zelgen
Donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab for unresectable hepatocellular carcinoma (uHCC): A prospective, single-arm phase II trial (DoHAICs study) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2543;
P2
Conclusions Combination treatment with donafenib and HAIC plus sintilimab showed promising clinical benefits and acceptable toxic effects in pts with uHCC. The enrollment and follow-up are continuing.
- Zepsun (donafenib) / Suzhou Zelgen
Transarterial chemoembolization combined donafenib with/without programmed death-1 inhibitors for initially unresectable hepatocellular carcinoma in a multicenter retrospective study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2540;
There was no significant difference in the incidence and severity of adverse events in the TACE+DP and TACE+D groups (any grade, 92.9% vs. 94.6%, P=0.270; grade 3 or 4, 33.8% vs. 37.3%, P=0.253). Conclusions With favorable safety and tolerability, TACE combined donafenib with PD-1 inhibitors significantly improves PFS, OS, and ORR over TACE combined with donafenib.