Chidamide and Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 2
- 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 sintilimab in chemotherapy-refractory advanced high-grade neuroendocrine neoplasm.
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. Six patients with high-grade neuroendocrine neoplasm will be enrolled in the first stage. If more than one complete or partial responses were seen at planned interim analysis, the additional 17 patients will be recruited in the second stage and a total of 23 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 advanced and metastatic high-grade neuroendocrine neoplasm;
- •Receive ≤ 2 types of chemotherapy for high-grade neuroendocrine tumors and had tumor progression;
- •Have at least one measurable lesion according to RECIST version 1.1;
- •Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
- •Provide tumor samples for pathological diagnosis and PD-L1 biomarker detection;
- •Have ability to sign a written informed consent.
排除标准
- •Small cell lung cancer;
- •Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
- •Previous use of HDAC inhibitors;
- •Previous use of PD-1/PD-L1/PD-L2/CTLA-4 inhibitors;
- •Allergy to related drug components;
- •Have a medical history of immune deficiency diseases, or organ transplantation;
- •Have active autoimmune diseases requiring treatment or a medical history of autoimmune diseases in the past 2 years;
- •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 ;
- •Receive any live or live attenuated vaccine within 4 weeks before enrollment;
- •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 + Sintilimab
Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months.
干预措施: Chidamide (Drug)
Chidamide + Sintilimab
Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months.
干预措施: Sintilimab (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)