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

Sponsor
Fudan University
Study ID
NCT06591650
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gallbladder Cancer Unresectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 24, 2024
Status verified
May 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab
    Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes and nab-paclitaxel over 30 minutes on days 1 and 8. Durvalumab intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months. ]

Central Contacts