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

July 13, 2019 updated by: yu gengsheng, Jiangmen Central Hospital

Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Jiangmen, Guangdong, China, 529000
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Toripalimab combined with Gem/5-FU
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.
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
Other Names:
  • Gem
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
Other Names:
  • 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month PFS rate
Time Frame: 6-month after the beginning of first line systemic therapy
the rate of 6-month progression free survival
6-month after the beginning of first line systemic therapy
mPFS
Time Frame: 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
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
Toxic side effects
Time Frame: 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
from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 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
from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
DCR
Time Frame: 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
from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
1-year OS rate
Time Frame: 1 year after the beginning of the first line systemic therapy
the rate of 1-year overall survival
1 year after the beginning of the first line systemic therapy
mOS
Time Frame: 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
from the beginning of the first line systemic therapy until the date of death from any cause,assessed up to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the value of PD-1/PD-L1
Time Frame: 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
from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
the value of MMR
Time Frame: 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
from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangmen Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2019

Primary Completion (ANTICIPATED)

May 30, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 9, 2019

First Posted (ACTUAL)

June 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 13, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cholangiocarcinoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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