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

Primary Purpose

Advanced Cholangiocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Gemcitabine
5- fluorine pyrimidine
Sponsored by
Jiangmen Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cholangiocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jiangmen central hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toripalimab combined with Gem/5-FU

Arm 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.

Outcomes

Primary Outcome Measures

6-month PFS rate
the rate of 6-month progression free survival
mPFS
the median of progression free survival
Toxic side effects
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0

Secondary Outcome Measures

ORR
the objective response rate
DCR
the disease control rate
1-year OS rate
the rate of 1-year overall survival
mOS
the median of overall survival

Full Information

First Posted
June 7, 2019
Last Updated
July 13, 2019
Sponsor
Jiangmen Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03982680
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangmen Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toripalimab combined with Gem/5-FU
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
3mg/kg on d1 and d15 q4W*4cycles，then 3mg/kg q3w for 1 year in total
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gem
Intervention Description
1250mg/m2 on d1 and d15 q4W*4cycles
Intervention Type
Drug
Intervention Name(s)
5- fluorine pyrimidine
Other Intervention Name(s)
5-FU
Intervention Description
400mg/m2 intravenous injection plus 5-FU 2.4g-3.6g/m2 continuous intravenous drip for 48h on d1 and d15 q4W*4cycles
Primary Outcome Measure Information:
Title
6-month PFS rate
Description
the rate of 6-month progression free survival
Time Frame
6-month after the beginning of first line systemic therapy
Title
mPFS
Description
the median of progression free survival
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
Title
Toxic side effects
Description
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0
Time Frame
from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
Secondary Outcome Measure Information:
Title
ORR
Description
the objective response rate
Time Frame
from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
Title
DCR
Description
the disease control rate
Time Frame
from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
Title
1-year OS rate
Description
the rate of 1-year overall survival
Time Frame
1 year after the beginning of the first line systemic therapy
Title
mOS
Description
the median of overall survival
Time Frame
from the beginning of the first line systemic therapy until the date of death from any cause,assessed up to 24 months
Other Pre-specified Outcome Measures:
Title
the value of PD-1/PD-L1
Description
to analyze the predictive value of PD-1/PD-L1 for efficacy and toxicity
Time Frame
from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
Title
the value of MMR
Description
to analyze the predictive value of MMR for efficacy and toxicity
Time Frame
from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deng wenjing, master
Phone
(+86)07503165905
Email
wjdeng2011@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu gengsheng, master
Phone
(+86)07503165915
Email
gengsheng_yu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu gengsheng, master
Organizational Affiliation
jiangmen cenctral hospital
Official's Role
Study Director
Facility Information:
Facility Name
Jiangmen central hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjing Deng, master
Phone
+8607503165905
Email
wjdeng2011@163.com
First Name & Middle Initial & Last Name & Degree
Gengsheng Yu, master
Phone
+8607503165905
Email
gengsheng_yu@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma

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