NCT07436741招募中3 期
A Prospective, Randomized, Controlled, Multi-center Clinical Trial of Surufatinib Combined With Gemcitabine and Nab-paclitaxel Versus Gemcitabine Combined With Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年3月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Surgical complete resection rate (R0)
研究概览
简要总结
To explore the efficacy and safety of surufatinib in combination with AG regimen verus AG regimen as peri-operative treatment in high - risk resectable or borderline resectable pancreatic cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Histologically or cytologically confirmed high-risk resectable or borderline resectable pancreatic cancer;
- •18-75 years old (including 18 and 75 years old);
- •No BRCA1/2 or PALB2 mutation;
- •No previous pancreatic cancer resection, systemic therapy, or local radiation therapy;
- •Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- •Life expectancy ≥ 6 months;
- •At least one measurable lesion according to RECIST version 1.1;
- •Adequate organ and bone marrow functions;
- •Women of childbearing age need to take effective contraceptive measures.
排除标准
- •With distant metastasis;
- •Have received blood transfusion treatment, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
- •Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);
- •Allergic to the study drug or any of its adjuvants;
- •Researchers judged clinically significant electrolyte abnormalities;
- •History of serious cardiovascular and cerebrovascular diseases;
- •With active ulcer, intestinal perforation and intestinal obstruction;
- •Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture according to the judgment of the investigator);
- •Clinically significant electrolyte abnormalities judged by researchers;
- •With active bleeding or obvious evidence of bleeding tendency;
- •Hypertension that cannot be controlled by drugs: systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 100 mmHg;
- •Women who are pregnant or lactating;
- •Urinary protein ≥ ++, or the 24-hour urine protein quantification is greater than 1.0g;
- •Concurrent tumors within 5 years (except treated cervical carcinoma in situ, basal cell carcinoma);
- •Any disease or state that affects the absorption of drugs, or the subject cannot take oral drugs;
- •Known human immunodeficiency virus (HIV) infection;
- •History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml or >2000 IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×10^3/m); hepatitis and cirrhosis;
- •Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not suitable for enrolling according to the judgment of the investigator.
结局指标
主要结局
Surgical complete resection rate (R0)
时间窗: about 1 year
This is a complete macroscopic resection of the gross tumor with negative surgical margins
次要结局
- Disease Control Rate (DCR)(about 1 year)
- Downstaging Rate(about 1 year)
- Pathological complete response (pCR) rate(about 1 year)
- Overall survival (OS)(about 5 years)
- Adverse events (AEs)(about 2 years)
- Event-free survival (EFS)(about 2 years)
- Objective Response Rate (ORR)(about 1 year)
研究者
研究点 (1)
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