drugset / Trial / NCT06591650

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

NCT06591650 ↗

Phase 2 Recruiting 33 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-10-24
Primary completion
2026-10-30
Completion
2027-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Gemcitabine Small molecule 800 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous

Indications