Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07261592
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Entinostat — DRUG
    Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).
  • Chemotherapy — DRUG
    Gisantinib and cisplatin chemotherapy for 6 cycles, 21 days per cycle. Gisantinib 1000mg/m2 is given intravenously on Day 1 and 8 for each cycle while cisplatin 70mg/m2 is given intravenously on Day2.

Study Details

This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.

Key Dates

First listed
Dec 3, 2025
Start date
Dec 1, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2028
Completion
Apr 30, 2029

Study Design

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

Arms

  • Experimental: Entinostat plus chemotherapy
    The study was divided into two phases: chemotherapy phase and continuous treatment phase. During chemotherapy phase, patients receive 6 cycles of GC (gemcitabine and cisplatin) chemotherapy along with entinostat followed by efficacy evaluation. If stable disease is reached according to RECIST 1.1 criteria, patients may receive continuous entinostat treatment until disease progression or intolerable side effects.

Primary Outcome Measure

Objective response rate, ORR [ Time Frame: 36 months ]

Central Contacts

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