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Clinical Trials in China / NCT07261592
Starting soon Phase 1/2

Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

NCT07261592 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase
Phase 1/2
Started
2025-12-01
Last updated
2025-12-03

Condition(s) studied

Bladder CancerHistone Deacetylase InhibitorEntinostatChemotherapy

Investigational drug(s) / intervention(s)

EntinostatChemotherapy

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

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

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07261592 on ClinicalTrials.gov ↗ ← All trials in China