Clinical trial NCT04979663: GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer
Official title: Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Biliary Tract Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety: the incidence of adverse events and serious adverse events
timeFrame: 3 weeks
Secondary outcomes:
measure: Disease control rate
timeFrame: 6 weeks
measure: Overall response rate
timeFrame: 6 weeks
measure: Conversion rate
timeFrame: 6 weeks
measure: Overall survival
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Lu Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: