Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210008, China
NCT Number: NCT07261592
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Nanjing, Jiangsu, 210008, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 36 months
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
OS refers to the time from the beginning of treatment to death from any reason.
Time frame: 36 months
The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy.
Contact information is provided by the study sponsor or research team.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial
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