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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Huai'an First People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection (QL1706) in combination with Regorafenib	Iparomlimab and Tuvonralimab Injection (QL1706) in combination with Regorafenib

Timeline

• Start date: 2025-08-26
• Primary completion: 2027-08-26
• Completion: 2028-08-26
• First posted: 2025-08-11
• Last updated: 2025-08-11