NCT06591650

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gallbladder Cancer Unresectable

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	800 mg/m\^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.
DRUG	Cisplatin	25 mg/m\^2, intravenous (IV) over 60 minutes, Days 1,8, every 21 days.
DRUG	Nab-paclitaxel	100 mg/m\^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.
DRUG	Durvalumab	1500mg, intravenous (IV) over 30 minutes, Days 1, every 21 days.

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-03-15
• Completion: 2027-09-15
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study