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Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract Cancer

Primary Purpose

Biliary Tract Carcinoma, Initially Unresectable

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 and ≤80 years;
  2. ECOG 0~1;
  3. Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder;
  4. Imaging assessment of disease stage III/IVA/any TN1M0*;
  5. The main organs have good functions and the examination indexes meet the following requirements:
  6. Blood routine test:

    Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophils count ≥1.5×10^9/L; Platelet count ≥80×10^9/L;

  7. Biochemical tests:

    Total bilirubin ≤2×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula);

  8. Voluntarily signed the informed consent;
  9. Good compliance and family members are willing to cooperate with follow-up.

Exclusion Criteria:

  1. Other uncured malignancies;
  2. Pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial;
  3. Previous anti-tumor therapy for the disease in this study;
  4. Participated in other drug clinical trials within one month;
  5. Patients with known history of other systemic serious diseases before screening;
  6. Long-term unhealed wounds or incomplete healed fractures;
  7. Have a history of organ transplantation;
  8. Abnormal blood coagulation, with bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5;
  9. The incidence of arterial/venous thrombosis events in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism, was screened;
  10. People with a history of psychotropic substance abuse and unable to get rid of it or with mental disorders; Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;

12. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

combined treatment group

Arm Description

Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab Gemcitabine: 1000mg/m^2, iv, d1, d8, q3w Oxaliplatin: 100mg/m^2, iv, d1, q3w Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 5mg/kg, d1, q3w

Outcomes

Primary Outcome Measures

objective response rate
objective response rate

Secondary Outcome Measures

Safety:the incidence of adverse events and serious adverse events
Incidence of adverse events and serious adverse events
disease control rate
disease control rate
progress-free survival
progress-free survival
overall survival
overall survival

Full Information

First Posted
July 26, 2021
Last Updated
January 24, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04984980
Brief Title
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract Cancer
Official Title
Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

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

5. Study Description

Brief Summary
Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Conversion rate; Secondary endpoints: Safety, disease control rate, disease-free survival, and overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab; Sample size: 34 patients; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 3 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 4.0; Follow up: 12 months after the last case was enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Carcinoma, Initially Unresectable

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
combined treatment group
Arm Type
Experimental
Arm Description
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab Gemcitabine: 1000mg/m^2, iv, d1, d8, q3w Oxaliplatin: 100mg/m^2, iv, d1, q3w Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 5mg/kg, d1, q3w
Intervention Type
Drug
Intervention Name(s)
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
Intervention Description
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
Primary Outcome Measure Information:
Title
objective response rate
Description
objective response rate
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Safety:the incidence of adverse events and serious adverse events
Description
Incidence of adverse events and serious adverse events
Time Frame
3 weeks
Title
disease control rate
Description
disease control rate
Time Frame
3 weeks
Title
progress-free survival
Description
progress-free survival
Time Frame
3 weeks
Title
overall survival
Description
overall survival
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤80 years; ECOG 0~1; Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder; Imaging assessment of disease stage III/IVA/any TN1M0*; The main organs have good functions and the examination indexes meet the following requirements: Blood routine test: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophils count ≥1.5×10^9/L; Platelet count ≥80×10^9/L; Biochemical tests: Total bilirubin ≤2×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula); Voluntarily signed the informed consent; Good compliance and family members are willing to cooperate with follow-up. Exclusion Criteria: Other uncured malignancies; Pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial; Previous anti-tumor therapy for the disease in this study; Participated in other drug clinical trials within one month; Patients with known history of other systemic serious diseases before screening; Long-term unhealed wounds or incomplete healed fractures; Have a history of organ transplantation; Abnormal blood coagulation, with bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5; The incidence of arterial/venous thrombosis events in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism, was screened; People with a history of psychotropic substance abuse and unable to get rid of it or with mental disorders; Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 12. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract Cancer

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