Actively Recruiting
GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma
Led by Fudan University · Updated on 2026-01-14
93
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this phase 2 study, the investigators aim to evaluate the effects and safety of combined therapy using oxaliplatin and gemcitabine chemotherapy, Donafenib and Tislelizumab for patients with advanced biliary tract carcinoma.
CONDITIONS
Official Title
GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older and up to 75 years
- ECOG physical condition score of 0 or 1
- Histologically or cytologically confirmed advanced biliary tract carcinoma including gallbladder, intrahepatic, or extrahepatic cholangiocarcinoma
- Disease stage III or IV based on preoperative imaging
- At least one measurable lesion according to mRECIST criteria
- Child-Pugh classification A or B
- Good function of main organs with blood tests showing hemoglobin 60 g/L or higher (no blood transfusion within 14 days), neutrophil count 1.5�d710^9/L or higher, platelet count 80�d710^9/L or higher
- Biochemical tests with total bilirubin no more than 2 times upper normal limit; ALT or AST no more than 2.5 times upper normal limit; endogenous creatinine clearance 50 mL/min or higher
- Normal thyroid function with thyroid stimulating hormone within normal range, or T3 and T4 within normal range if TSH is abnormal
- Myocardial enzyme profile within normal range or minor abnormalities not clinically significant
- Estimated survival time of 3 months or longer
- Voluntary signing of informed consent
- Good compliance and family support for follow-up
You will not qualify if you...
- Presence of other uncured malignant tumors
- Pregnancy or lactation; pregnant participants must withdraw if pregnancy occurs during the study
- Previous antitumor therapy for biliary tract carcinoma
- Participation in other drug clinical trials within one month prior
- Known history of serious systemic diseases before screening
- Obstructive jaundice not resolved by treatment; patients can join after liver function returns to normal
- Untreated active hepatitis B (HBsAg positive and high HBV-DNA levels)
- Active hepatitis C infection (HCV antibody positive with detectable HCV RNA)
- Allergy to any study drug or its ingredients
- Long-term unhealed wounds or incomplete bone fractures
- History of organ transplantation
- History of psychotropic substance abuse or ongoing mental disorders
- History of immune deficiency or organ transplantation
- Any conditions judged by investigators to seriously risk safety or study completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200062
Actively Recruiting
Research Team
L
Lu Wang, M.D.
CONTACT
Y
Yiming Zhao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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