Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy; Bladder Cancer; Histone Deacetylase Inhibitor; Entinostat
• Intervention / Treatment: Drug: Entinostat; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hongqian Guo, PhD
• Study Contact Backup: Name: Junlong Zhuang, PhD; Phone Number: 15950451917; Email: zhuangjl-2008@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ProgressionFree Survival, PFS	PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first).	36 months
Overall Survival, OS	OS refers to the time from the beginning of treatment to death from any reason.	36 months
Disease Control Rate, DCR	The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy.	36 months

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Principal Investigator: Hongqian Guo, PhD, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Therapeutics; Drug Therapy; entinostat
• Other Study ID Numbers: IUNU-UC-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No