Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Advanced Extrapulmonary Neuroendocrine Carcinoma: a Prospective, Multicenter, Single-arm, Phase 2 Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of chidamide combined with etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma.
详细描述
This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Twelve patients with extrapulmonary neuroendocrine carcinoma will be enrolled in the first stage. If more than four complete or partial responses were seen at planned interim analysis, the additional 16 patients will be recruited in the second stage and a total of 28 patients will be treated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma;
- •No systematic treatments for neuroendocrine carcinoma are received before enrollment;
- •Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments;
- •Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
- •Have ability to sign a written informed consent.
排除标准
- •Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
- •Previous use of HDAC inhibitors;
- •Allergy to related drug components;
- •Have a medical history of immune deficiency diseases, or organ transplantation;
- •Have uncontrolled or significant cardiovascular disease;
- •Abnormal liver function (total bilirubin > 1.5×upper limit of normal); Transaminases (ALT/AST) >2.5×upper limit of normal (>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine > 1.5×upper limit of normal);
- •Pregnancy ;
- •Have serious diseases that may endanger the safety of patients, or affect patients to complete the research;
- •Any serious mental or cognitive disorder;
- •Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment;
- •Any other condition which is inappropriate for the study in the opinion of the investigators.
研究组 & 干预措施
Chidamide + Etoposide + Cisplatin/Carboplatin
Experimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles.
干预措施: Chidamide (Drug)
Chidamide + Etoposide + Cisplatin/Carboplatin
Experimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles.
干预措施: Etoposide + Cisplatin/Carboplatin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 2 years
Percentage of participants with complete response and partial response, assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
次要结局
- Disease Control Rate (DCR)(Up to 2 years)
- Progression-free Survival (PFS)(Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years)
- Overall Survival (OS)(Time from the date of enrollment to the earliest of documented death, assessed up to 3 years)
- Treatment-related Adverse Events (Safety)(Up to 2 years)