Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma

Phase 2

• Conditions: Advanced Cholangiocarcinoma
• Interventions: Drug: Toripalimab; Drug: Gemcitabine; Drug: 5- fluorine pyrimidine

• Registration Number: NCT03982680
• Lead Sponsor: Jiangmen Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-09
• Study First Posted: 2019-06-11
• Status Verified: 2019-07
• Study Start: 2019-07-13
• Last Update Submitted: 2019-07-13
• Last Update Posted: 2019-07-16
• Primary Completion: 2021-05-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toripalimab combined with Gem/5-FU	Toripalimab	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.
Toripalimab combined with Gem/5-FU	Gemcitabine	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.
Toripalimab combined with Gem/5-FU	5- fluorine pyrimidine	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 Outcome Measures

Name	Time	Method
6-month PFS rate	6-month after the beginning of first line systemic therapy	the rate of 6-month 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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Jiangmen central hospital; 🇨🇳 Jiangmen, Guangdong, China