Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |