NCT05908747已完成2 期
Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Locally Advanced or Borderline Resectable Pancreatic Cancer: An Exploratory Study
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Surgical complete resection rate (R0)
研究概览
简要总结
This study is designed to explore the efficacy and safety of surufatinib combined with gemcitabine and nab-paclitaxel as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer.
详细描述
This is a phase II, multi-centered, open-label study, aims to explore the efficacy and safety of surufatinib (250mg, qd po) combined with gemcitabine (1000mg/m2, I.V, d1/8/15, Q4W) and nab-paclitaxel (125mg/m2, I.V, d1/8/15, Q4W) as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer. Potential therapeutic biomarkers will also be explored.
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
- •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 systematic treatment or radiotherapy;
- •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: -Absolute neutrophil count≥1.5x10^9/L; -Platelet count≥100x10^9/L; -Hemoglobin≥9g/dL; -Serum bilirubin≤1.5x the upper limit of normal (ULN); -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5x ULN; -Serum creatinine≤1.5x ULN or endogenous creatinine clearance rate ≥ 60ml / min; -INR≤1.5×ULN, PT and APTT≤1.5×ULN；
- •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: -Cerebrovascular accident (excluding lacunar cerebral infarction, minor cerebral ischemia or transient ischemic attack), myocardial infarction, unstable angina pectoris, and poorly controlled arrhythmia (including QTc interval ≥ 450ms for male and ≥ 470ms for female) occurred within 6 months before the first administration of the study drug (QTc interval was calculated by fridericia formula); -New York Heart Association (NYHA) cardiac function classification > grade II or left ventricular ejection fraction (LVEF) < 50%;
- •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.
研究组 & 干预措施
surufatinib + gemcitabine + nab-paclitaxel
Experimental
干预措施: surufatinib + gemcitabine + nab-paclitaxel (Drug)
结局指标
主要结局
Surgical complete resection rate (R0)
时间窗: about 2 years
This is a complete macroscopic resection of the gross tumor with negative surgical margins
次要结局
- Objective Response Rate (ORR)(about 2 years)
- Downstaging Rate(about 2 years)
- Adverse events (AEs)(about 2 years)
- Disease Control Rate (DCR)(about 2 years)
- Surgical Resection Rate(about 2 years)
- Overall survival (OS)(about 5 years)
- Disease-free survival (DFS)(about 3 years)
- Recurrence Free Survival (RFS)(about 3 years)
- Pathological complete response (pCR) rate(about 2 years)
- Major pathological response (MPR)(about 2 years)
研究者
研究点 (1)
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