Biliary Tract Carcinoma
Conditions
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.
Interventions
COMBINATION_PRODUCTCombination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤80 years; 2. ECOG physical condition score: 0\ 1; 3. Histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system; 4. Preoperative imaging assessment of the disease stage was III/IV; 5. 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
1. Patients with other uncured malignant tumors; 2. Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period; 3. Previous antitumor therapy for the disease in this study; 4. Participated in clinical trials of other drugs within one month; 5. Patients with a known history of other systemic serious diseases before screening; 6. Long-term unhealed wounds or incomplete healing fractures; 7. Previous organ transplantation history; 8. Abnormal coagulation function; 9. Screening for overactivity/venous thrombosis events in the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 10. Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders; 11. A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 12. Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: the incidence of adverse events and serious adverse events | 3 weeks | Incidence of adverse events and serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 6 weeks | Disease control rate |
| Overall response rate | 6 weeks | Overall response rate |
| Conversion rate | 6 weeks | Conversion rate |
| Overall survival | 6 weeks | Overall survival |
Countries
China
Contacts
Primary ContactLu Wang, M.D.
Outcome results
None listed