NCT07152769

Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC

Iparomlimab and Tuvonralimab Combined With Gemcitabine and Cisplatin (GC) Versus Sintilimab Combined With GC as First-Line Treatment for Advanced Intrahepatic Cholangiocarcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC.

Detailed description

This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC. The primary endpoint is investigator-assessed 6-month Progression-Free Survival Rate . Secondary endpoints include ORR, DCR, DoR, TTR, PFS, OS, AE. This study plans to enroll 104 patients with advanced ICC. These patients are assigned in a 1:1 ratio to the Iparomlimab and Tuvonralimab Combined With GC group (experimental group) and Sintilimab Combined With GC group (control group).

Conditions

• Advanced Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab + GC	Iparomlimab and Tuvonralimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w
DRUG	Sintilimab + GC	Sintilimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w.

Timeline

• Start date: 2025-10-15
• Primary completion: 2028-02-29
• Completion: 2028-12-31
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

1 site across 1 country: China