NCT01980407Unknown2 期
A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer
Jilin Provincial Tumor Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •Histologically or cytologically documented gastric adenocarcinoma
- •Performance status (ECOG scale): 0-2
- •Life expectancy ≥ 3 months
- •No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
- •Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
- •WIth Measurable Target lesion
- •Patients should sign a written informed consent before study entry
排除标准
- •History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product
- •Inadequate hematopoietic function: WBC≦5,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
- •Inadequate organ function which is defined as below:
- •Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 2 upper limit of normal range (ULN);
- •Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1;
- •Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine;
- •Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;
- •Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication;
- •History of ventricular arrhythmia or congestive heart failure;
- •Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study;
- •Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes
研究组 & 干预措施
SOL, single arm
Experimental
S-1 combined with leucovorin and oxaliplatin
干预措施: S-1, leucovorin, oxaliplatin (Drug)
结局指标
主要结局
Response rate
时间窗: 6-8 weeks
Evaluate the objective response rate followed by RECIST 1.1.
次要结局
- Progress free survival(up to 9 weeks)
- Adverse events(1 year)
- Overall survival(3 year)
- Disease control rate(up to 9 weeks)
研究者
Zhang Yue
Head of Department of Integrated Traditional Chinese and Western Medicine
Jilin Provincial Tumor Hospital
研究点 (1)
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