RecruitingPhase 2NCT06591650

Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer

A Phase II Study of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Durvalumab in Locally Advanced or Metastatic Gallbladder Cancer


Sponsor

Fudan University

Enrollment

33 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cisplatin, a drug called Durvalumab, and others for people with gallbladder cancer unresectable. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGgemcitabine hydrochloride

800 mg/m\^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.

DRUGCisplatin

25 mg/m\^2, intravenous (IV) over 60 minutes, Days 1,8, every 21 days.

DRUGNab-paclitaxel

100 mg/m\^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.

DRUGDurvalumab

1500mg, intravenous (IV) over 30 minutes, Days 1, every 21 days.


Locations(1)

Hepatobiliary Surgery Center, Department of General Surgery, Huashan Hospital & Cancer Metastasis Institute, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06591650