drugset / Trial / NCT07115550
A Single-center, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Regorafenib in the Treatment of Advanced Second-line or Above Hepatocellular Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
This study is a prospective, single-center, phase II clinical trial designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706) combined with regorafenib in patients with advanced hepatocellular carcinoma (HCC) who have received at least one prior line of systemic therapy. The trial employs a single-arm design. Study endpoint Primary endpoint: ORR Secondary endpoint: DCR, PFS, and OS evaluated based on RECIST v1.1. The incidence and severity of adverse events (AEs)
Timeline
- Start
- 2025-08-26
- Primary completion
- 2027-08-26
- Completion
- 2028-08-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iparomlimab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Regorafenib | Small molecule | 8 mg | — |
| Subject | Regorafenib | Small molecule | 12 mg | — |
| Subject | Tuvonralimab | Monoclonal antibody | 5 mg/kg | — |