drugset / Trial / NCT07328009
A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase II, multi-arm, Bayesian adaptive platform trial designed to efficiently evaluate novel therapies for advanced hepatocellular carcinoma (HCC) after first-line treatment failure. The study aims to rapidly identify the most effective investigational regimens and discover predictive biomarker signatures (from tumor tissue, blood, and imaging) to guide personalized second-line therapy.
Timeline
- Start
- 2026-01-19
- Primary completion
- 2029-01-15
- Completion
- 2029-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Lenvatinib | Small molecule | 8 mg | Oral |
| Comparator | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | QL1706 | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Comparator | Regorafenib | Small molecule | 80 mg | Oral |
| Comparator | Regorafenib | Small molecule | 160 mg | Oral |
| Subject | Taurursodiol | Small molecule | 250 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |