NCT07515469

A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With Iparomlimab and Tuvonralimab Injection, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

Conditions

• HCC - Hepatocellular Carcinoma
• Iparomlimab and Tuvonralimab Injection
• Neoadjuvant Immunotherapy

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab	Patients in the neoadjuvant Iparomlimab and Tuvonralimab group received 2 cycles of 7.5 mg/kg iv d1 q3w, followed by elective surgery 2-3 weeks thereafter.

Timeline

• Start date: 2026-05-30
• Primary completion: 2028-05-30
• Completion: 2030-10-30
• First posted: 2026-04-07
• Last updated: 2026-04-07