GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Biliary Tract Carcinoma
• Intervention / Treatment: Combination product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lu Wang, M.D.; Phone Number: +86-18121299357; Email: w.lr@hotmail.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Lu Wang, M.D.; Phone Number: +86-18121299357; Email: w.lr@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Combination of Gemox, Donafenib and Tislelizumab	Combination product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab; Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Lu Wang, M.D., Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Oxaliplatin
• Other Study ID Numbers: 2021-07-2310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No