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Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC

NCT07152769 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Advanced Intrahepatic Cholangiocarcinoma

Interventions

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2028-02-29
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07152769 on ClinicalTrials.gov