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

NCT06591650 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-05-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Lun xiu Qin · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2026-10-30
Completion
2027-10-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06591650 on ClinicalTrials.gov