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NCT Number: NCT07261592

Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Objective response rate, ORR

    Time frame: 36 months

    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.

Secondary outcomes

  1. ProgressionFree Survival, PFS

    Time frame: 36 months

    PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first).

  2. Overall Survival, OS

    Time frame: 36 months

    OS refers to the time from the beginning of treatment to death from any reason.

  3. Disease Control Rate, DCR

    Time frame: 36 months

    The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongqian Guo, PhD

CONTACT

Junlong Zhuang, PhD

CONTACT

[email protected]

15950451917

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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