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

NCT03982680 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-16

No results posted yet for this study

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.

Conditions

  • Advanced Cholangiocarcinoma

Interventions

DRUG

Toripalimab

3mg/kg on d1 and d15 q4W\*4cycles，then 3mg/kg q3w for 1 year in total

DRUG

Gemcitabine

1250mg/m2 on d1 and d15 q4W\*4cycles

DRUG

5- 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 & Collaborators

  • Jiangmen Central Hospital

    lead OTHER

Principal Investigators

  • Yu gengsheng, master · jiangmen cenctral hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-13
Primary Completion
2021-05-30
Completion
2021-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03982680 on ClinicalTrials.gov