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  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    P2 data, Journal, PD(L)-1 Biomarker, IO biomarker:  Camrelizumab combined with apatinib and nanoparticle albumin-bound paclitaxel in lung adenocarcinoma (CAPAP-lung): a single-arm phase II study. (Pubmed Central) -  Jan 23, 2024   
    P2
    Heath Research Foundation of Chinese Society of Clinical Oncology, Hunan Provincial Natural Science Foundation of China, Hunan Cancer Hospital Climb Plan, Sister Institution Network Fund of The University of Texas MD Anderson Cancer Center, The Science and Technology Innovation Program of Hunan Province, and Suzhou Sheng Diya Biomedical Co., Ltd, a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Shanghai, China).
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    Trial completion date, Trial primary completion date:  Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC (clinicaltrials.gov) -  Jan 23, 2024   
    P2/3,  N=62, Recruiting, 
    In patients with RM-NPC, apatinib plus camrelizumab showed promising antitumor activity and manageable toxicities. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: May 2023 --> Sep 2024
  • ||||||||||  Retrospective data, Journal:  New First-line Immunotherapy-based Therapies for Unresectable Hepatocellular Carcinoma: A Living Network Meta-analysis. (Pubmed Central) -  Jan 22, 2024   
    The combination therapies, apart from atezolizumab plus cabozantinib in OS and durvalumab plus tremelimumab in PFS, had higher P-score than single-agent MTAs or ICIs...This NMA demonstrated that atezolizumab plus bevacizumab remains the stand of care and confers comparable survival benefits to sintilimab plus IBI305 and camrelizumab plus apatinib in first-line therapy for uHCC. The optimal treatment algorithms should consider efficacy, safety, and etiology.
  • ||||||||||  5-fluorouracil / Generic mfg.
    Journal, Combination therapy, Metastases:  Development and validation of a nomogram to predict pathological complete response in patients with locally advanced gastric adenocarcinoma treated with neoadjuvant chemotherapy in combination with PD-1 antibodies. (Pubmed Central) -  Jan 10, 2024   
    Clinical and pathological characteristics of patients with GC who received neoadjuvant chemotherapy combined with PD-1 inhibitor (camrelizumab) therapy and radical gastrectomy between January 2019 and December 2020 at the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital were retrospectively analyzed...The neoadjuvant regimen consisted of a combination of PD-1 inhibitor and fluorouracil analogues plus oxaliplatin, comprising two drugs...Neoadjuvant chemotherapy combined with PD-1 antibodies may be the preferred option for patients with advanced gastric adenocarcinoma who have a small tumor diameter, no or few lymph node metastases, and high CPS. The presented nomogram model exhibits the potential to predict pCR in advanced gastric adenocarcinoma patients, showcasing satisfactory predictive performance and potentially facilitating the implementation of personalized treatment strategies.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, AiRuiKa (camrelizumab) / HLB Bio Group
    Journal, Checkpoint inhibition:  Variable PD-1 glycosylation modulates the activity of immune checkpoint inhibitors. (Pubmed Central) -  Jan 9, 2024   
    We then provide evidence that the concentration of fucosylated PD-1 in the blood of non-small-cell lung cancer patients varies across different stages of disease. This study illustrates how glycoprofiling of surface receptors and related circulating forms can inform the development of differentiated antibodies that discriminate glycosylation variants and achieve enhanced selectivity, and paves the way toward the implementation of personalized therapeutic approaches.
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, AiRuiKa (camrelizumab) / HLB Bio Group
    P2 data, Journal, Metastases:  Neoadjuvant camrelizumab and apatinib combined with chemotherapy versus chemotherapy alone for locally advanced gastric cancer: a multicenter randomized phase 2 trial. (Pubmed Central) -  Jan 8, 2024   
    P2
    In this multicenter, randomized, phase 2 trial (NCT04195828), patients with gastric adenocarcinoma (clinical T2-4N?+?M0) were randomly assigned (1:1) to receive neoadjuvant camrelizumab and apatinib combined with nab-paclitaxel plus S-1 (CA-SAP) or chemotherapy SAP alone (SAP) for 3 cycles...Survival results were not reported due to immature data. Camrelizumab and apatinib combined with chemotherapy as a neoadjuvant regimen was tolerable and associated with favorable responses for LAGC.
  • ||||||||||  Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, AiRuiKa (camrelizumab) / HLB Bio Group
    Review, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker:  Immune checkpoint inhibitors in gastrointestinal malignancies: an Umbrella review. (Pubmed Central) -  Jan 6, 2024   
    We also assessed the correlation of PD-L1 expression as well as microsatellite status with the extent of the response to ICIs; overall, high expression of PD-L1 in GI cancers is associated with better response to ICIs, however, additional studies are required to precisely elaborate ICI responses with respect to microsatellite status in different GI tumors. Despite encouraging ICI efficacy in some GI cancers, a greater number of serious and fatal adverse events have been observed; further highlighting the fact that ICI therapy in GI cancers is not without cost, and further studies are required to utmost optimization of this approach in GI cancers.
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Trial completion, Trial completion date, Trial primary completion date:  Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer (clinicaltrials.gov) -  Jan 5, 2024   
    P2,  N=60, Completed, 
    Despite encouraging ICI efficacy in some GI cancers, a greater number of serious and fatal adverse events have been observed; further highlighting the fact that ICI therapy in GI cancers is not without cost, and further studies are required to utmost optimization of this approach in GI cancers. Recruiting --> Completed | Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group, Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Journal, Surgery:  Clinical efficacy and safety evaluation of camrelizumab plus lenvatinib in adjuvant therapy after hepatocellular carcinoma surgery. (Pubmed Central) -  Jan 3, 2024   
    Recruiting --> Completed | Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 This retrospective cohort study included HCC patients who, after undergoing failed postoperative adjuvant lenvatinib therapy, received intravenous camrelizumab 200 mg every 3 weeks (C group, n = 97), camrelizumab plus oral apatinib 250 mg daily (C+A group, n = 125), camrelizumab plus oral lenvatinib 12 mg daily (for bodyweight ?60 kg)/lenvatinib 8 mg daily (for bodyweight <60
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Trial suspension:  Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer (clinicaltrials.gov) -  Jan 3, 2024   
    P1/2,  N=30, Suspended, 
    This retrospective cohort study included HCC patients who, after undergoing failed postoperative adjuvant lenvatinib therapy, received intravenous camrelizumab 200 mg every 3 weeks (C group, n = 97), camrelizumab plus oral apatinib 250 mg daily (C+A group, n = 125), camrelizumab plus oral lenvatinib 12 mg daily (for bodyweight ?60 kg)/lenvatinib 8 mg daily (for bodyweight <60 Active, not recruiting --> Suspended
  • ||||||||||  MODULE 2: Optimal Use of Immune Checkpoint Inhibitors as First-Line Therapy for Advanced HCC () -  Jan 2, 2024 - Abstract #ASCOGI2024ASCO_GI_934;    
    This activity is supported by an educational grant from AstraZeneca Pharmaceuticals LP. Key factors affecting the selection of first-line treatment for advanced HCC Long-term findings from the Phase III IMbrave150 study comparing first-line atezolizumab/bevacizumab to sorafenib for advanced unresectable HCC; optimal integration into routine practice Correlation between antidrug antibody levels and clinical outcomes following treatment with atezolizumab/bevacizumab for advanced HCC Design, eligibility criteria and key efficacy and safety endpoints for the pivotal Phase III HIMALAYA trial evaluating the combination of durvalumab/tremelimumab in patients with previously untreated, advanced HCC Published efficacy and safety findings, including 4-year OS results, from HIMALAYA; current clinical role Similarities and differences between patient populations enrolled in IMbrave150 and HIMALAYA; implications for the interpretation of available findings Available Phase III data with and potential role of other novel front-line strategies (eg, anti-PD-1/PD-L1 monotherapy, camrelizumab/rivoceranib) in advanced HCC
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Enrollment change, Trial completion date, Trial primary completion date:  Safety and Efficacy of Camrelizumab for High-risk NMIBC Failing BCG Treatment (clinicaltrials.gov) -  Dec 28, 2023   
    P1/2,  N=25, Recruiting, 
    Key factors affecting the selection of first-line treatment for advanced HCC Long-term findings from the Phase III IMbrave150 study comparing first-line atezolizumab/bevacizumab to sorafenib for advanced unresectable HCC; optimal integration into routine practice Correlation between antidrug antibody levels and clinical outcomes following treatment with atezolizumab/bevacizumab for advanced HCC Design, eligibility criteria and key efficacy and safety endpoints for the pivotal Phase III HIMALAYA trial evaluating the combination of durvalumab/tremelimumab in patients with previously untreated, advanced HCC Published efficacy and safety findings, including 4-year OS results, from HIMALAYA; current clinical role Similarities and differences between patient populations enrolled in IMbrave150 and HIMALAYA; implications for the interpretation of available findings Available Phase III data with and potential role of other novel front-line strategies (eg, anti-PD-1/PD-L1 monotherapy, camrelizumab/rivoceranib) in advanced HCC N=56 --> 25 | Trial completion date: Jun 2023 --> Dec 2024 | Trial primary completion date: Sep 2022 --> Feb 2024
  • ||||||||||  Trial completion date, Trial primary completion date:  FUTURE-SUPER: An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC. (clinicaltrials.gov) -  Dec 22, 2023   
    P2,  N=139, Active, not recruiting, 
    PD-L1 expression detection and ethnicity differences are still of great significance and most suitable regimens varied from each subgroup. Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> May 2023
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Journal, Checkpoint inhibition:  Immune checkpoint inhibitor induced colitis and arthritis: A case report. (Pubmed Central) -  Dec 19, 2023   
    Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> May 2023 This article describes the cases of immune-related colitis and arthritis caused by camrelizumab, and recommends considering the risk of colitis and arthritis with camrelizumab monotherapy or combination therapy.
  • ||||||||||  Sulanda (surufatinib) / Hutchmed, AiRuiKa (camrelizumab) / HLB Bio Group
    Enrollment open, Trial primary completion date:  CCGLC-005: A Clinical Study of DEB-TACE Combined With Surufatinib and Camrelizumab in the Treatment of Inoperable or Metastatic ICC (clinicaltrials.gov) -  Dec 19, 2023   
    P2,  N=18, Recruiting, 
    This article describes the cases of immune-related colitis and arthritis caused by camrelizumab, and recommends considering the risk of colitis and arthritis with camrelizumab monotherapy or combination therapy. Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2023 --> Jun 2024
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    Enrollment closed, Trial completion date, Trial primary completion date:  CAP-ACE: TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma (clinicaltrials.gov) -  Dec 17, 2023   
    P=N/A,  N=188, Active, not recruiting, 
    Results of this post-hoc analysis may have implications for selection of initial and subsequent therapies for uHCC patients. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jan 2026 | Trial primary completion date: Sep 2023 --> Aug 2024
  • ||||||||||  luxeptinib (CG-806) / Aptose Biosci
    Trial completion date, Trial primary completion date:  A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas (clinicaltrials.gov) -  Dec 15, 2023   
    P1,  N=160, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jan 2026 | Trial primary completion date: Sep 2023 --> Aug 2024 Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Feb 2024
  • ||||||||||  luxeptinib (CG-806) / Aptose Biosci
    Enrollment closed, Trial completion date, Trial primary completion date:  A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS (clinicaltrials.gov) -  Dec 15, 2023   
    P1,  N=80, Active, not recruiting, 
    Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Feb 2024 Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Feb 2024