Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer (NCT07261592) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer
China29 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Objective response rate, ORR
Timeframe: 36 months
Trial details
NCT IDNCT07261592
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School