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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).
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.
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
Objective response rate, ORR
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.
Time frame: 36 months
ProgressionFree Survival, PFS
PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first).
Time frame: 36 months
Overall Survival, OS
OS refers to the time from the beginning of treatment to death from any reason.
Time frame: 36 months
Disease Control Rate, DCR
The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy.
Time frame: 36 months
Hongqian Guo, PhD
CONTACT
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