临床试验/NCT04135781

NCT04135781招募中3 期

Adjuvant Nab-paclitaxel Plus S-1 Versus Capecitabine Plus Oxaliplatin for Patients With Stage III Gastric Cancer After D2 Gastrectomy : a Randomised，Open-label, Phase III Study

Zhejiang Cancer Hospital1 个研究点分布在 1 个国家目标入组 616 人开始时间: 2020年3月1日最近更新: 2020年3月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: Zhejiang Cancer Hospital
入组人数: 616
试验地点: 1
主要终点: 3 years Diseases-free Survival rate(3 years-DFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

详细描述

This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting. The primary endpoint is the 3-year diseases-free survival (DFS) rate. The secondary endpoints are the overall survival (OS) and safety.

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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age of 18-75 years;
•Histological diagnosis of stage III gastric adenocarcinoma and Gastroesophageal junction of the stomach;
•Patients are required to provide a pathologically confirmed diagnosis report and provide 4-5 histological white films obtained at baseline;;
•Patients underwent D2 radical resection within 6 weeks prior to random enrollment; and R0 resection criteria were achieved;
•Ability to perform chemotherapy within 7 days of enrollment in the randomized group;
•No prior anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy for primary lesions;
•ECOG performance status of 0-1;
•Haematological status: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥100×109 /L, hemoglobin(HB) ≥90 g/L;WBC ≥3.0×109 /L;And no bleeding tendency;
•Liver function: alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), alkaline phosphatase ≤2.5 x upper limit of normal range (ULN)；total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤3 x upper limit of normal range (ULN) when with Gilbert's syndrome;
•kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN) or Creatinine clearance >60 ml/min (calculated according to Cockroft-Gault)
•Able and willing to comply with the study plans in this protocol and sign the informed consent;

排除标准

•Treat with any other study drug or participate in another clinical trial with therapeutic intent within 28 days prior to enrollment;
•postoperative complications requiring clinical intervention and affecting treatment, such as stomach cramps, dumping syndrome;
•Patients known to be allergic or intolerant to clinical trial drugs;
•investigator believes will affect the subject's treatment regimen, uncontrolled serious medical diseases, including severe heart disease (such as the New York Heart Association (NYHA) Level II or more Congestive heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection；
•Known active infection with HIV, hepatitis B or hepatitis C;
•Other serious and uncontrolled non-malignant disease; except adequately treated cervical carcinoma in situ, non-melanoma skin Localized prostate cancer after cancer and radical surgery (PSA ≤ 10 ng/ml); no recurrence or metastasis was found based on imaging follow-up results and any disease-specific tumor markers;
•accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation;
•Female patients during pregnancy or lactation, who are refused to receive contraception during the childbearing age;
•The investigator judges patients who are not suitable for the study.

研究组 & 干预措施

AS

Experimental

Arm A：nab paclitaxel （120mg/m2；iv；d1，8）+S-1 （<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）Q3W；up to eight cycles

干预措施: nab paclitaxel (Drug)

AS

Experimental

Arm A：nab paclitaxel （120mg/m2；iv；d1，8）+S-1 （<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）Q3W；up to eight cycles

干预措施: Tegafur (Drug)

XELOX

Active Comparator

Arm B：Capetabine（1000 mg/m2 po, d1-14 bid ）+ Oxaliplatin（130mg/m2 , iv, d1）Q3W；up to eight cycles

干预措施: Oxaliplatin (Drug)

XELOX

Active Comparator

Arm B：Capetabine（1000 mg/m2 po, d1-14 bid ）+ Oxaliplatin（130mg/m2 , iv, d1）Q3W；up to eight cycles

干预措施: Capecitabine (Drug)

结局指标

主要结局

3 years Diseases-free Survival rate(3 years-DFS)

时间窗: up to 3 years

DFS is defined as time from the date of inclusion up to the date of disease progression or death

次要结局

Overall survival (OS)(up to 3 years)
Safety as measured by number and grade of adverse events(up to 3 years)

研究者

发起方

Zhejiang Cancer Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Xiangdong Cheng

Director

Zhejiang Cancer Hospital

研究点 (1)

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