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

Jiangmen Central Hospital

Status and phase: Unknown; Phase 2

Conditions: Advanced Cholangiocarcinoma

Treatments: Drug: 5- fluorine pyrimidine; Drug: Gemcitabine; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT03982680

cholangiocarcinoma

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Toripalimab combined with Gem/5-FU

Experimental group

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.

Treatment:

Drug: 5- fluorine pyrimidine

Drug: Gemcitabine

Drug: Toripalimab