Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective response rate, ORR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Entinostat plus chemotherapy
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.
干预措施: Entinostat (Drug)
Entinostat plus chemotherapy
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.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective response rate, ORR
时间窗: 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.
次要结局
- ProgressionFree Survival, PFS(36 months)
- Overall Survival, OS(36 months)
- Disease Control Rate, DCR(36 months)
研究者
Hongqian Guo
Chief physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School