GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

  • STATUS
    Recruiting
  • End date
    Jun 16, 2022
  • participants needed
    10
  • sponsor
    Fudan University
Updated on 16 August 2021

Summary

Study design: Prospective, single-arm, single-center study; Primary endpoint: Safety; Secondary endpoints: Disease control rate, overall response rate, conversion rate, overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab; Sample size: 10 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 2 circles of treatment (6 weeks), 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 Biliary Tract Carcinoma
Treatment Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
Clinical Study IdentifierNCT04979663
SponsorFudan University
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years and 80 years
ECOG physical condition score: 0~1
Histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system
Preoperative imaging assessment of the disease stage was III/IV
The main organs function well, and the examination indicators meet the following
requirements
Routine blood tests: Hemoglobin 90 g/L (no blood transfusion within 14 days)
Neutrophil count 1.510^9/L; Platelet count 8010^9/L; Biochemical examination
Total bilirubin 2ULN (upper normal value); ALT or AST 2.5ULN; Endogenous
creatinine clearance 50 mL /min (Cockcroft-Gault formula); 6. Sign the
informed consent voluntarily; 9. Good compliance, and family members willing
to cooperate with follow-up

Exclusion Criteria

Patients with other uncured malignant tumors
Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period
Previous antitumor therapy for the disease in this study
Participated in clinical trials of other drugs within one month
Patients with a known history of other systemic serious diseases before screening
Long-term unhealed wounds or incomplete healing fractures
Previous organ transplantation history
Abnormal coagulation function
Screening for overactivity/venous thrombosis events in the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism
Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders
A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study
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