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NCT06591650

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

Not yet recruiting Phase 2 Last updated 19 September 2024
What this trial tests

Phase 2 trial testing gemcitabine hydrochloride in Gallbladder Cancer Unresectable in 33 participants. Not yet recruiting.

Timeline
10 September 2024
Primary endpoint
15 March 2026
15 September 2027

Quick facts

Lead sponsorFudan University
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date10 September 2024
Primary completion15 March 2026
Estimated completion15 September 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Fudan University

Who can join

18 and older, any sex, with Gallbladder Cancer Unresectable. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Global gene expression landscape of gallbladder cancer and advances in targeted therapeutic strategies.
    Choudhury S, Maiti A, Bandopadhyay A, Tripathi A, et al · · 2025 · cited 1× · PMID 41178912 · DOI 10.5306/wjco.v16.i10.111028

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Other trials of gemcitabine hydrochloride

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