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)
Objective response rate, ORR — 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.
Trial sites (1)
Facility
City
Region
Status
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
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.
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