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

Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma

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.

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.