NCT06954116

Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence

A Prospective, Open-Label, Single-Arm, Exploratory Clinical Study on the Anti-Recurrence Effect of Neoadjuvant Iparomlimab and Tuvonralimab in Resectable Hepatocellular Carcinoma With High Risk of Recurrence After Radical Resection

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the impact of iparomlimab and tuvonralimab as preoperative neoadjuvant therapy on recurrence-free survival (RFS), along with its potential improvement in overall survival (OS), in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence.

Detailed description

CCGLC-017 is a prospective, open-label, single-arm, exploratory clinical study. This study primarily evaluates the impact of iparomlimab and tuvonralimab (QL1706) as preoperative neoadjuvant therapy on recurrence-free survival (RFS), with exploratory analysis of its potential benefits on overall survival (OS) in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence. Enrolled patients will receive a single dose of iparomlimab and tuvonralimab within one week prior to surgery, followed by six cycles of iparomlimab and tuvonralimab therapy postoperatively.

Conditions

• Resectable Hepatocellular Carcinoma With High Risk of Recurrence

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab (QL1706)	Neoadjuvant phase: A single cycle of Iparomlimab and Tuvonralimab (7.5 mg/kg) will be administered within 1 week prior to surgery. Adjuvant phase: Six cycles of Iparomlimab and Tuvonralimab (7.5 mg/kg, Q3W) will be initiated starting at 2 weeks postoperatively.
PROCEDURE	Partial hepatectomy	Will be performed at an appropriate interval following neoadjuvant therapy initiation.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-12-31
• Completion: 2029-04-01
• First posted: 2025-05-01
• Last updated: 2025-06-13

Locations

1 site across 1 country: China