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

Biliary Tract Carcinoma Clinical Trial

Official title:

Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04984980
• Other study ID #: 2020-176-2096
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: July 2023

Study information

• Verified date: January 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Biliary Tract Neoplasms

Intervention

Drug:
• Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	objective response rate	3 weeks
Secondary	Safety:the incidence of adverse events and serious adverse events	Incidence of adverse events and serious adverse events	3 weeks
Secondary	disease control rate	disease control rate	3 weeks
Secondary	progress-free survival	progress-free survival	3 weeks
Secondary	overall survival	overall survival	3 weeks