Clinical trial NCT03982680: Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma
Official title: Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Cholangiocarcinoma
Lead sponsor: Jiangmen Central Hospital
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 6-month PFS rate
timeFrame: 6-month after the beginning of first line systemic therapy
measure: mPFS
timeFrame: 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
measure: Toxic side effects
timeFrame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
Secondary outcomes:
measure: ORR
timeFrame: from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
measure: DCR
timeFrame: from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
measure: 1-year OS rate
timeFrame: 1 year after the beginning of the first line systemic therapy
measure: mOS
timeFrame: from the beginning of the first line systemic therapy until the date of death from any cause,assessed up to 24 months
Other outcomes:
measure: the value of PD-1/PD-L1
timeFrame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
measure: the value of MMR
timeFrame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
Locations:
city: Jiangmen
country: China
facility: Jiangmen central hospital
state: Guangdong
Study officials:
affiliation: jiangmen cenctral hospital
name: Yu gengsheng, master
role: STUDY_DIRECTOR
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