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

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04984980
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Carcinoma; Initially Unresectable	Drug: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: combined treatment group 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	Drug: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab; Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab

Outcome Measures

Primary Outcome Measures

1. Conversion rate [12 weeks]

   Conversion rate

Secondary Outcome Measures

1. Safety：the incidence of adverse events and serious adverse events [12 weeks]

   Incidence of adverse events and serious adverse events

2. disease control rate [12 weeks]

   disease control rate

3. progress-free survival [12 weeks]

   progress-free survival

4. overall survival [12 weeks]

   overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

1. 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);

1. Voluntarily signed the informed consent;

2. 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;

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fudan University
• ClinicalTrials.gov Identifier: NCT04984980
• Other Study ID Numbers: 2020-176-2096
• First Posted: Aug 2, 2021
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Biliary Tract Neoplasms; Gemcitabine; Bevacizumab; Oxaliplatin

Study Results

No Results Posted as of Aug 6, 2021