Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Entinostat, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Bladder Cancer, Histone Deacetylase Inhibitor, Entinostat, Chemotherapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Objective response rate, ORR [Time frame: 36 months]
Secondary outcome measures (3)
- ProgressionFree Survival, PFS [Time frame: 36 months]
- Overall Survival, OS [Time frame: 36 months]
- Disease Control Rate, DCR [Time frame: 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institut — Nanjing
Identifiers
NCT: NCT07261592 · IUNU-UC-108