Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT07152769
Brief 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).
Study:
NCT07152769
Study Brief:
Protocol Section:
NCT07152769