Back to results

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

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:

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.

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

Secondary Outcome Measures

Safety：the incidence of adverse events and serious adverse events

Incidence of adverse events and serious adverse events

disease control rate

progress-free survival

overall survival

Full Information

NCT ID

NCT04984980

First Posted

July 26, 2021

Last Updated

January 24, 2023

Sponsor

Fudan University

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs