NCT06038461招募中1 期
An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib Combined With Temozolomide and S-1 as the first-line treatment of advanced neuroendocrine tumors
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
- •Aged 18-75years (inclusive);
- •Histopathologically confirmed diagnosis of advanced MGMT0/1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis);
- •Previously untreated with systemic therapy;
- •Have at least one measurable lesion according to RECIST v1.1;
- •ECOG performance status: 0-2(determined by investigator);
- •Expected survival time > 3 months;
- •Adequate hepatic, renal, heart, and hematologic functions;
- •Urine protein < ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
- •Before the first dose, serum HCG examination of potential childbearing-women must be negative; Men/Women of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion.
排除标准
- •Neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid,
- •Functional NETs which need to control symptoms by long-acting somatostatin analogues;
- •Received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment;
- •Have uncontrolled hypertension, defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
- •Patients with active ulcer, intestinal perforation and intestinal obstruction;
- •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 Combined With Temozolomide and S-1
Experimental
Patients will receive surufatinib combined with temozolomide and S-1 once every three weeks as the second-line treatment until disease progression or intolerable toxicity or patients withdrawal of consent.
Phase I: DLTs of surufatinib combined with temozolomide and S-1 will be evaluated based on NCI CTCAE v 5.0 in the first cycle.
干预措施: Surufatinib Combined With Temozolomide and S-1 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: approximately 1 years
the proportion of patients with complete response or partial response, using RESIST v1.1
次要结局
- Progression-Free Survival (PFS)(approximately 1 years)
- Disease Control Rate (DCR)(approximately 1 years)
研究者
Yihebali Chi, MD
Professor, Department of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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