A Clinical Study Evaluating the Use of HLX10 in Combination With HLX04 for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients

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

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “As of February 7, 2023, the combination therapy of serplulimab and HLX04 was well tolerated in patients with aHCC in the first-line setting.” henlius.com ↗

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

Indications