NCT07279532尚未招募2 期
Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 35 人开始时间: 2026年1月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 主要终点
- Recurrence Free Survival（RFS）
研究概览
简要总结
The following issues warrant in-depth investigation: further refinement of staging by primary tumor site, the increasing prognostic weight of T classification, risk assessment for lymph node metastasis and postoperative recurrence/distant metastasis, and whether NET G3 with poor prognosis requires more aggressive postoperative intervention. This study plans to enroll patients classified as Stage III according to the AJCC 9th Edition staging system, including NET G1/G2 and all G3 patients, for a clinical trial on postoperative adjuvant therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent and voluntarily participate in the study.
- •Aged 18-80 years, male or female.
- •Confirmed as Stage III NET G1/G2 or any-stage NET G3 after surgical treatment.
- •Other postoperative NET patients deemed by the investigator to have high-risk factors.
- •Adequate organ function meeting the following criteria (no use of any blood components, cell growth factors, or corrective drugs within 14 days prior to the first dose of the study drug): (i) Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; (ii) Platelets ≥100×10⁹/L; (iii) Hemoglobin ≥8 g/dL; (iv) Total Bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (or ≤5 × ULN if liver metastases are present); (v) Serum Creatinine ≤1.5 × ULN or Creatinine Clearance >60 mL/min (Cockcroft-Gault formula).
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first study drug dose and use effective contraception during the study and for at least 3 months after the last dose. Male subjects with female partners of childbearing potential must use effective contraception during the study and for 3 months after the last dose.
排除标准
- •Major surgery, open biopsy, or significant trauma within 28 days prior to the first dose.
- •History of severe or poorly controlled interstitial lung disease.
- •Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite antihypertensive medication.
- •Poorly controlled cardiovascular diseases, including but not limited to:
- •(i)NYHA Class II or higher heart failure; (ii) Unstable angina; (iii) Myocardial infarction within the past year; (iv) Clinically significant supraventricular or ventricular arrhythmias poorly controlled with or without intervention.
- •Significant bleeding tendency or clinically significant bleeding within 3 months prior to the first dose (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis).
- •Arterial/venous thrombotic events within 6 months prior to the first dose (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism). Superficial vein thrombosis may be enrolled if deemed eligible by the investigator.
- •Concurrent active malignancy requiring treatment, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- •Pregnancy or lactation.
- •Any other condition deemed by the investigator to potentially lead to study discontinuation (e.g., severe comorbid illnesses, abnormal laboratory values, psychosocial issues).
研究组 & 干预措施
Experimental Group
Experimental
Surufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy.
干预措施: surufatinib (Drug)
结局指标
主要结局
Recurrence Free Survival（RFS）
时间窗: 4 years
Refers to the time from when a patient achieves complete response after anticancer therapy or surgery until the occurrence of disease recurrence or death from any cause.
次要结局
- Overall Survival （OS）(4 years)
- Adverse Event (AE)(4 years)
研究者
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