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

  • STATUS
    Recruiting
  • days left to enroll
    49
  • participants needed
    32
  • sponsor
    Fudan University
Updated on 15 August 2021

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.

Details
Condition Initially Unresectable Biliary Tract Carcinoma, Initially Unresectable, Biliary Tract Carcinoma
Treatment Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
Clinical Study IdentifierNCT04984980
SponsorFudan University
Last Modified on15 August 2021

Eligibility

Yes No Not Sure

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
510^9/L; Platelet count 8010^9/L
\. Biochemical tests
Total bilirubin 2ULN (upper limit of normal value); Blood alanine
aminotransferase (ALT) or blood aspartate aminotransferase (AST) 2.5ULN
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
Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study
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