GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

NCT04979663 | Unknown Phase 1 DMC

• 1 other identifier: 2021-07-2310
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.successfully conversed to resectable disease
2. 2.progressed disease
3. 3.intolerable toxicity
4. 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.

Conditions

Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety: the incidence of adverse events and serious adverse events

  Incidence of adverse events and serious adverse events

  3 weeks

Secondary Outcomes (4)

• Disease control rate

  6 weeks

• Overall response rate

  6 weeks

• Conversion rate

  6 weeks

• Overall survival

  6 weeks

Study Arms (1)

experimental group

EXPERIMENTAL

Combination of Gemox, Donafenib and Tislelizumab

Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

Interventions

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab COMBINATION_PRODUCT

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

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤80 years;
• ECOG physical condition score: 0\~1;
• Histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system;
• Preoperative imaging assessment of the disease stage was III/IV;
• 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.

You may not qualify if:

• Patients with other uncured malignant tumors;
• Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;
• Previous antitumor therapy for the disease in this study;
• Participated in clinical trials of other drugs within one month;
• Patients with a known history of other systemic serious diseases before screening;
• Long-term unhealed wounds or incomplete healing fractures;
• Previous organ transplantation history;
• Abnormal coagulation function;
• Screening for overactivity/venous thrombosis events in the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
• Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
• A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; donafenib; tislelizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Lu Wang, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Wang, M.D.

CONTACT

+86-18121299357; w.lr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver surgery department

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: July 28, 2021
• Study Start: December 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-07

Locations

CN (1)