NCT02131493已完成2 期
A Open-label, Randomized Study of S-1 and and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer
Zhejiang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
This study is a randomized, open-label, controlled study that will compare the efficacy of S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients with surgically resected pancreatic adenocarcinoma.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
- •Pancreatic cancer surgical staging: T 1-3, N0-1, M
- •Subject should be able to start treatment no later than 12 weeks postsurgery.
- •≥18 years of age at the time of signing the informed consent form (ICF).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Acceptable hematology parameters:
- •Absolute neutrophil count ≥1500 cell/mm3
- •Platelet count ≥100,000/mm3
- •Hemoglobin (Hgb) ≥9 g/dL
- •Acceptable blood chemistry levels:
- •Aspartate aminotransferase (AST)/ Serum glutamic oxaloacetic transaminase (SGOT) and Alanine transaminase (ALT)/ Serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
- •Total bilirubin ≤ Upper Limit of Normal (ULN) (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
- •Alkaline phosphatase ≤ 2.5 x ULN
- •Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m
- •If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead
- •Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
- •Acceptable coagulation studies as demonstrated by Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within normal limits (±15%)
排除标准
- •Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
- •Presence of or history of metastatic pancreatic adenocarcinoma
- •.Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
- •Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- •Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- •History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
- •Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
- •.History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa) 2).History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies 3).History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
研究组 & 干预措施
Gemcitabine
Active Comparator
Gemcitabine：1000mg/m2，iv 30min，d1, d8,d15 q4w, 6 cycles
干预措施: S-1, Gemcitabine (Drug)
S-1+ Gemcitabine
Experimental
S-1：40~60mg bid，d1~14; (S-1 dosage：BSA <1.25m2，40mg bid，1.25m2≤BSA≤1.5m2，50mg bid，BSA>1.5m2， 60mg bid) Gemcitabine：1000mg/m2，iv 30min，d1, d8 q3w, 8 cycles
干预措施: S-1, Gemcitabine (Drug)
结局指标
主要结局
DFS
时间窗: 3 years
Disease free survival
次要结局
- OS(5 years)
研究者
Weijia Fang, MD
First affiliated hospital, Zhejiang university
Zhejiang University
研究点 (1)
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