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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entinostat plus chemotherapy | Experimental | The study was divided into two phases: chemotherapy phase and continuous treatment phase. During chemotherapy phase, patients receive 6 cycles of GC (gemcitabine and cisplatin) chemotherapy along with entinostat followed by efficacy evaluation. If stable disease is reached according to RECIST 1.1 criteria, patients may receive continuous entinostat treatment until disease progression or intolerable side effects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entinostat | Drug | Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| ProgressionFree Survival, PFS | PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first). | 36 months |
| Overall Survival, OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junlong Zhuang, PhD | Contact | 15950451917 | zhuangjl-2008@163.com | |
| Hongqian Guo, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Hongqian Guo, PhD | Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C118739 | entinostat |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Chemotherapy | Drug | 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. |
|
OS refers to the time from the beginning of treatment to death from any reason.
| 36 months |
| Disease Control Rate, DCR | The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy. | 36 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |