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GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

Primary Purpose

Biliary Tract Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

About this trial

This is an interventional treatment trial for Biliary Tract Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group

Arm Description

Combination of Gemox, Donafenib and Tislelizumab

Outcomes

Primary Outcome Measures

Safety: the incidence of adverse events and serious adverse events

Incidence of adverse events and serious adverse events

Secondary Outcome Measures

Disease control rate

Overall response rate

Conversion rate

Overall survival

Full Information

NCT ID

NCT04979663

First Posted

July 27, 2021

Last Updated

August 5, 2021

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04979663

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: successfully conversed to resectable disease progressed disease intolerable toxicity 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

Combination of Gemox, Donafenib and Tislelizumab

Intervention Type

Combination Product

Intervention Name(s)

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety: the incidence of adverse events and serious adverse events

Description

Incidence of adverse events and serious adverse events

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Disease control rate

Description

Disease control rate

Time Frame

6 weeks

Title

Overall response rate

Description

Overall response rate

Time Frame

6 weeks

Title

Conversion rate

Description

Conversion rate

Time Frame

6 weeks

Title

Overall survival

Description

Overall survival

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Wang, M.D.

Phone

+86-18121299357

w.lr@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lu Wang, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lu Wang, M.D.

Phone

+86-18121299357

w.lr@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

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