About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Entinostat
- Chemotherapy