Overview
Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma
Status:
Recruiting
Recruiting
Trial end date:
2021-12-30
2021-12-30
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jiangmen Central HospitalTreatments:
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.