GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

Biliary Tract Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979663
• Other study ID #: 2021-07-2310
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: June 2022

Study information

• Verified date: July 2021
• Source: Fudan University
• Contact: Lu Wang, M.D.
• Phone: +86-18121299357
• Email: w.lr[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Biliary Tract Neoplasms

Intervention

Combination Product:
• Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: the incidence of adverse events and serious adverse events	Incidence of adverse events and serious adverse events	3 weeks
Secondary	Disease control rate	Disease control rate	6 weeks
Secondary	Overall response rate	Overall response rate	6 weeks
Secondary	Conversion rate	Conversion rate	6 weeks
Secondary	Overall survival	Overall survival	6 weeks