GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer
- Conditions
- Biliary Tract Carcinoma
- Interventions
- Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
- Registration Number
- NCT04979663
- Lead Sponsor
- Fudan University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description experimental group Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab Combination of Gemox, Donafenib and Tislelizumab
- Primary Outcome Measures
Name Time Method Safety: the incidence of adverse events and serious adverse events 3 weeks Incidence of adverse events and serious adverse events
- Secondary Outcome Measures
Name Time Method Conversion rate 6 weeks Conversion rate
Overall survival 6 weeks Overall survival
Overall response rate 6 weeks Overall response rate
Disease control rate 6 weeks Disease control rate
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China