Overview

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.