Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Advanced Cholangiocarcinoma
- Sponsor
- Jiangmen Central Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Toxic side effects
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
yu gengsheng
Vice director of Oncology department
Jiangmen Central Hospital
Eligibility 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.
Arms & Interventions
Toripalimab combined with Gem/5-FU
All patients were given Toripalimab 3 mg/kg (day 1 and 15); Gem+5-FU (Gem 1250mg/m2+CF 200 mg/m2+5-FU400 mg/m2 intravenous drip+5-FU 2.4-3.6 g/m2 continuous intravenous drip for 48 hours), the first and fifteenth days, four weeks for a cycle, a total of four cycles.After 4 cycles, Toripalimab was maintained at 3 mg/kg Q3 w for a total of 1 year if the disease was not progressing or toxic side effects were tolerated.
Intervention: Toripalimab
Toripalimab combined with Gem/5-FU
All patients were given Toripalimab 3 mg/kg (day 1 and 15); Gem+5-FU (Gem 1250mg/m2+CF 200 mg/m2+5-FU400 mg/m2 intravenous drip+5-FU 2.4-3.6 g/m2 continuous intravenous drip for 48 hours), the first and fifteenth days, four weeks for a cycle, a total of four cycles.After 4 cycles, Toripalimab was maintained at 3 mg/kg Q3 w for a total of 1 year if the disease was not progressing or toxic side effects were tolerated.
Intervention: Gemcitabine
Toripalimab combined with Gem/5-FU
All patients were given Toripalimab 3 mg/kg (day 1 and 15); Gem+5-FU (Gem 1250mg/m2+CF 200 mg/m2+5-FU400 mg/m2 intravenous drip+5-FU 2.4-3.6 g/m2 continuous intravenous drip for 48 hours), the first and fifteenth days, four weeks for a cycle, a total of four cycles.After 4 cycles, Toripalimab was maintained at 3 mg/kg Q3 w for a total of 1 year if the disease was not progressing or toxic side effects were tolerated.
Intervention: 5- fluorine pyrimidine
Outcomes
Primary Outcomes
Toxic side effects
Time Frame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0
6-month PFS rate
Time Frame: 6-month after the beginning of first line systemic therapy
the rate of 6-month progression free survival
mPFS
Time Frame: from the beginning of the first line systemic therapy until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 24 months
the median of progression free survival
Secondary Outcomes
- 1-year OS rate(1 year after the beginning of the first line systemic therapy)
- ORR(from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months)
- DCR(from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months)
- mOS(from the beginning of the first line systemic therapy until the date of death from any cause,assessed up to 24 months)