Advanced Cholangiocarcinoma
Conditions
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.
Interventions
DRUGToripalimab
3mg/kg on d1 and d15 q4W\*4cycles，then 3mg/kg q3w for 1 year in total
DRUGGemcitabine
1250mg/m2 on d1 and d15 q4W\*4cycles
DRUG5- fluorine pyrimidine
400mg/m2 intravenous injection plus 5-FU 2.4g-3.6g/m2 continuous intravenous drip for 48h on d1 and d15 q4W\*4cycles
Sponsors
Jiangmen Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mPFS | 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 |
| Toxic side effects | 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 | 6-month after the beginning of first line systemic therapy | the rate of 6-month progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mOS | from the beginning of the first line systemic therapy until the date of death from any cause,assessed up to 24 months | the median of overall survival |
| 1-year OS rate | 1 year after the beginning of the first line systemic therapy | the rate of 1-year overall survival |
| ORR | from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months | the objective response rate |
| DCR | from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months | the disease control rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| the value of PD-1/PD-L1 | from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months | to analyze the predictive value of PD-1/PD-L1 for efficacy and toxicity |
| the value of MMR | from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months | to analyze the predictive value of MMR for efficacy and toxicity |
Countries
China
Contacts
Primary ContactDeng wenjing, master
Backup ContactYu gengsheng, master
Outcome results
None listed