Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma

Sponsor
West China Hospital
Study ID
NCT06438822
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study aimed to evaluate the efficacy and safety of the combination of cadonilimab with liposomal irinotecan plus fluorouracil and leucovorin for the treatment of advanced biliary tract cancer.

Key Dates

Start date
Aug 30, 2024
Status verified
May 2024
Primary completion
Aug 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cadonilimab+NIFU regimen
    There will be two cohorts. Cohort 1 includes patients who have failed first-line treatment with gemcitabine-based chemotherapy combined with PD-L1/PD-1 monoclonal antibody immunotherapy. Cohort 2 includes patients who have failed chemotherapy with gemcitabine-based chemotherapy as a first-line treatment and who had not been treated with PD-L1/PD-1 monoclonal antibody immunotherapy.

Primary Outcome Measure

overall response rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts

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