GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

Study Overview
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Brief Summary
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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: successfully conversed to resectable disease progressed disease intolerable toxicity 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.

Official Title
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Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer

Conditions
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Biliary Tract Carcinoma

Intervention / Treatment
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* Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab


Participation Criteria
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Eligibility Criteria
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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 ≥1.5×10^9/L; Platelet count ≥80×10^9/L; Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Combination of Gemox, Donafenib and Tislelizumab | Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab<br>* Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: the incidence of adverse events and serious adverse events | Incidence of adverse events and serious adverse events | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | Disease control rate | 6 weeks | 
| Overall response rate | Overall response rate | 6 weeks | 
| Conversion rate | Conversion rate | 6 weeks | 
| Overall survival | Overall survival | 6 weeks |