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

NCT04984980 | Unknown Phase 2

• 1 other identifier: 2020-176-2096
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Carcinoma; Initially Unresectable

Outcome Measures

Primary Outcomes (1)

• objective response rate

  objective response rate

  3 weeks

Secondary Outcomes (4)

• Safety：the incidence of adverse events and serious adverse events

  3 weeks

• disease control rate

  3 weeks

• progress-free survival

  3 weeks

• overall survival

  3 weeks

Study Arms (1)

combined treatment group

EXPERIMENTAL

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

Interventions

Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab DRUG

Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab

combined treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Interventions

Oxaliplatin; sintilimab; Bevacizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver surgery department

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 2, 2021
• Study Start: August 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

CN (1)