GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

NCT ID: NCT04979663

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-06-30

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.

Conditions

Biliary Tract Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Combination of Gemox, Donafenib and Tislelizumab

Group Type: EXPERIMENTAL

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

Intervention Type: COMBINATION_PRODUCT

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks

Interventions

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Lu Wang, MD, PhD

Head of liver surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lu Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Wang, M.D.

Role: CONTACT

w.lr@hotmail.com

+86-18121299357

Facility Contacts

Lu Wang, M.D.

Role: primary

w.lr@hotmail.com

+86-18121299357

Other Identifiers

2021-07-2310

Identifier Type: -

Identifier Source: org_study_id