Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Toxic side effects
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Toripalimab (Drug)
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.
干预措施: Gemcitabine (Drug)
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.
干预措施: 5- fluorine pyrimidine (Drug)
结局指标
主要结局
Toxic side effects
时间窗: 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
时间窗: 6-month after the beginning of first line systemic therapy
the rate of 6-month progression free survival
mPFS
时间窗: 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
次要结局
- 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)
研究者
yu gengsheng
Vice director of Oncology department
Jiangmen Central Hospital