Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2029-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer Histone Deacetylase Inhibitor Entinostat Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Entinostat

Intervention Type DRUG

Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).

Chemotherapy

Intervention Type 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.

Interventions

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Entinostat

Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).

Intervention Type DRUG

Chemotherapy

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both;
* Failure of first-line treatment;
* There is at least one measurable lesion according to RECIST 1.1;
* Archived tumor tissue samples or tumor biopsies must be provided;
* ECOG score of 0-1 an an estimated survival of at least 6 months;
* Adequate organ function;
* Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;
* Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug.

Exclusion Criteria

* Patients who received platinum-based chemotherapy after failure of first-line treatment;
* Patients who received platinum-based chemotherapy withnin a 24 month before this trial;
* Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity);
* Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina;
* Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study;
* Patients with serious physical or mental illnesses.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No