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GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

NCT04979663 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-08-09

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Lu Wang, M.D. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979663 on ClinicalTrials.gov