Actively Recruiting
Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer
Led by Fudan University · Updated on 2026-05-14
33
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trail will evaluate the efficacy and safety of combining gemcitabine hydrochloride, cisplatin, nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation), with durvalumab in treating patients who have locally advanced or metastatic gallbladder cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab is a type of drug called a monoclonal antibody, which selectively blocks PD-L1 binding to PD-1. This anti-PD-L1 treatment works by allowing the immune system to detect your cancer and reactivates the immune response.
CONDITIONS
Official Title
Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed unresectable locally advanced or metastatic gallbladder adenocarcinoma
- At least 1 measurable disease per RECIST 1.1 at baseline
- Life expectancy of at least 3 months from proposed first dose date
- No prior anti-cancer therapy for gallbladder adenocarcinoma
- Adequate bone marrow, liver, and renal function measured within 14 days before treatment
- Women of childbearing potential must have a negative pregnancy test within 28 days before treatment and agree to use effective contraception until 90 days after last durvalumab dose
- Men must agree to remain abstinent or use contraception and refrain from sperm donation from screening to 90 days after last durvalumab dose
- Capable of giving written informed consent and able to comply with study protocol as judged by investigator
You will not qualify if you...
- Diagnosis of intrahepatic or extrahepatic cholangiocarcinoma or carcinoma of Vaters ampulla
- Known allergy to any study drugs or their ingredients
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy
- Active or past autoimmune or inflammatory disorders (e.g., colitis, Crohn's disease, lupus, sarcoidosis, rheumatoid arthritis)
- History of allogenic organ transplantation
- History of active primary immunodeficiency
- Uncontrolled illnesses including infections, heart failure, hypertension, angina, arrhythmia, lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance
- Myocardial infarction, transient ischemic attack, or stroke within 3 months prior to first treatment dose
- History of other primary malignancies unless treated with curative intent and no active disease for 5 years
- Active infections including tuberculosis, hepatitis B or C (with specific testing criteria)
- Use of immunosuppressive medication within 14 days before first durvalumab dose except specified exceptions
- Pregnant or breastfeeding women, or those unwilling to use effective birth control from screening to 90 days after last durvalumab dose
- Participation in another investigational clinical study within 4 weeks before first dose
- Concurrent enrollment in another clinical study unless observational or in follow-up period
- Judged unsuitable or unlikely to comply with study requirements by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hepatobiliary Surgery Center, Department of General Surgery, Huashan Hospital & Cancer Metastasis Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
X
Xiangyu Wang
CONTACT
S
Shenghao Wang
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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