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

NCT07115550

Not yet recruiting 24 enrolled Huai'an First People's Hospital
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

EvaluationDrugModalityDoseRoute
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