drugset / Trial / NCT03973112
A Clinical Study Evaluating the Use of HLX10 in Combination With HLX04 for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This trial is a single-arm, open, multicenter phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX10 + HLX04 intravenous infusion, every two weeks, lose treatment until clinical benefit, toxicity, the subjects of the resistance or the doctor decided to suspend the treatment, tested subjects death revocation of informed consent, subjects, subjects of pregnancy, not to plan or program requirement from, or management reasons, treatment for up to 2 years (before).
Timeline
- Start
- 2019-09-24
- Primary completion
- 2022-06-15
- Completion
- 2022-12-15
Publications
- Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.
- Ren Z, Shao G, Shen J, Zhang L, Zhu X, Fang W, Sun G, Bai Y, Wu J, Liu L, Yuan Y, Zhang J, Li Z, Zhang L, Yin T, Wu J, Hou X, Yu H, Li J, Wang Q, Zhu J, Fan J; Serplulimab-HCC Investigators. Phase 2 study of serplulimab with the bevacizumab biosimilar HLX04 in the first-line treatment of advanced hepatocellular carcinoma. Cancer Immunol Immunother. 2025 Jan 3;74(2):69. doi: 10.1007/s00262-024-03917-w.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 3 mg/kg | Intravenous |