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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Iparomlimab and Tuvonralimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2,iv,d1、d8,q3w; Cisplatin: 25 mg/m2,iv,d1、d8,q3w
Sintilimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2,iv,d1、d8,q3w; Cisplatin: 25 mg/m2,iv,d1、d8,q3w.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
6-month progression-free survival
Defined as the proportion of subjects who remain free of disease progression or death within 6 months from the start of the first study treatment.
Time frame: 6 months
Progression-Free Survival (PFS)
Defined as the time from randomization to the first documented radiological disease progression or death (whichever occurs first).
Time frame: up to approximately 2 years.
Objective Response Rate (ORR)
Defined as the proportion of subjects achieving a Complete Response (CR) or Partial Response (PR) among all subjects.
Time frame: up to approximately 2 years.
Disease Control Rate (DCR)
Defined as the proportion of subjects achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among all subjects.
Time frame: up to approximately 2 years.
Duration of Response (DOR)
Defined as the time from the first documented response (CR or PR) to disease progression or death (whichever occurs first).
Time frame: up to approximately 2 years.
Time to Response (TTR)
Defined as the time from randomization to the first documented Complete Response (CR) or Partial Response (PR).
Time frame: up to approximately 2 years.
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Time frame: up to approximately 2 years.
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Adverse Events
AE assessed by NCI-CTCAE v5.0.
Time frame: up to approximately 2 years.