NCT07261592

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
37mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Dec 2025Apr 2029

First Submitted

Initial submission to the registry

November 22, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

November 22, 2025

Last Update Submit

November 22, 2025

Conditions

Bladder CancerHistone Deacetylase InhibitorEntinostatChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Objective response rate, ORR

    ORR refers to the percentage of confirmed cases of complete response (CR) and partial response (PR) according to the RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1.

    36 months

Secondary Outcomes (3)

  • ProgressionFree Survival, PFS

    36 months

  • Overall Survival, OS

    36 months

  • Disease Control Rate, DCR

    36 months

Study Arms (1)

Entinostat plus chemotherapy

EXPERIMENTAL

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.

Drug: EntinostatDrug: Chemotherapy

Interventions

ChemotherapyDRUG

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.

Entinostat plus chemotherapy
EntinostatDRUG

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

Entinostat plus chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

entinostatDrug Therapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Hongqian Guo, PhD

    Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junlong Zhuang, PhD

CONTACT

15950451917zhuangjl-2008@163.com

Hongqian Guo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 3, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

April 30, 2029

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN(1)