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

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ClinicalTrials.gov Identifier: NCT03982680
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
yu gengsheng, 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.

Condition or disease Intervention/treatment Phase
Advanced Cholangiocarcinoma Drug: Toripalimab Drug: Gemcitabine Drug: 5- fluorine pyrimidine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma
Actual Study Start Date : July 13, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : December 30, 2021


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 Name: 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 Name: 5-FU




Primary Outcome Measures :
  1. 6-month PFS rate [ Time Frame: 6-month after the beginning of first line systemic therapy ]
    the rate of 6-month progression free survival

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 1-year OS rate [ Time Frame: 1 year after the beginning of the first line systemic therapy ]
    the rate of 1-year overall survival

  4. 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


Other Outcome Measures:
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982680


Contacts
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Contact: Deng wenjing, master (+86)07503165905 wjdeng2011@163.com
Contact: Yu gengsheng, master (+86)07503165915 gengsheng_yu@hotmail.com

Locations
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China, Guangdong
Jiangmen central hospital Recruiting
Jiangmen, Guangdong, China, 529000
Contact: Wenjing Deng, master    +8607503165905    wjdeng2011@163.com   
Contact: Gengsheng Yu, master    +8607503165905    gengsheng_yu@hotmail.com   
Sponsors and Collaborators
Jiangmen Central Hospital
Investigators
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Study Director: Yu gengsheng, master jiangmen cenctral hospital

Publications:

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Responsible Party: yu gengsheng, Vice director of Oncology department, Jiangmen Central Hospital
ClinicalTrials.gov Identifier: NCT03982680     History of Changes
Other Study ID Numbers: cholangiocarcinoma
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs