Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.
详细描述
This is a single-arm, multi-cohort, open-label, single-center, prospective, exploratory clinical study. We planned to enroll 80 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment of advanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.
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
- •Histopathologically confirmed locally advanced or metastatic unresectable ESCC, BTC, PC or GC with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CgA, Syn));
- •Have at least one measurable lesion according to RECIST v1.1;
- •ECOG performance status: 0-1;
- •No previous systemic therapy;
- •Urine protein< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
- •Expected survival time > 3 months;
排除标准
- •Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
- •With active bleeding or bleeding tendency;
- •Severe history of cardiovascular and cerebrovascular diseases;
- •Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
研究组 & 干预措施
Surufatinib + serplulimab + standard chemotherapy
干预措施: Surufatinib (Drug)
Surufatinib + serplulimab + standard chemotherapy
干预措施: Serplulimab (Drug)
Surufatinib + serplulimab + standard chemotherapy
干预措施: standard chemotherapy (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: approximately 1 years
time from first-dose to the first documented disease progression or death
次要结局
- Objective response rate (ORR)(approximately 1 years)
- Disease Control Rate (DCR)(approximately 1 years)
研究者
liwei wang
Director of department of oncology
RenJi Hospital