Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The study is a phase II clinical trial of single arm. The purpose is to evaluate the safety and efficacy of anti-PD-1 antibody Toripalimab combined with chemotherapy(gemcitabine+5-fluorine pyrimidine) in unresectable advanced cholangiocarcinoma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangmen Central Hospital
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• histologically or cytologically confirmed cholangiocarcinoma

• stage IV disease,no system therapy for advanced disease

• one or more lesions that can be measured by imaging assessment

• 18 to 70 years of age and life expectancy exceeds 3 months

• adequate specimens for detection of PD-1/PD-L1 and MMR

• karnofsky performance status(KPS) score ≥70%

• routine blood routine, liver and kidney function and electrocardiogram were basically normal without contraindication of chemotherapy.

Exclusion Criteria:

• dual cancers other than cholangiocarcinoma

• metastasis of central nervous system

• unreleased biliary obstruction

• acute infections requiring treatment

• non-infectious pneumonia requires glucocorticoid therapy, active autoimmune diseases, or systemic immunosuppressive therapy.