A Phase II Study of Neoadjuvant Chemotherapy With SEEOX Regimen Via Intra-arterial and Intravenous Administration Followed by Surgery for Borrmann Type 4 Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 2-year survival rate
研究概览
简要总结
Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. The purpose of this study is to determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.
详细描述
Gastric cancer patients who diagnosed as Borrmann type 4 would be included in this study.They would receive 3 cycles of neoadjuvant chemotherapy with SEEOX regimen via combined intra-arterial and intravenous administration. The treatment schedule consisted of 3 courses (each, 2-week administration and 1-week withdrawal) of intra-arterial administration of oxaliplatin (150mg), etoposide (100mg) and epirubicin(30mg) by Seldinger method on day 1 and oral S-1(120mg) on days 1-14, followed by radical surgery.The efficacy and toxicity of SEEOX regimen would be examined.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed gastric adenocarcinoma;
- •males or females, aged 30-70 years;
- •gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (without definitive ulceration) that invaded more than half of the stomach;
- •no peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
- •eastern Cooperative Oncology Group performance status of 0 or 1;
- •no serious concomitant diseases that make survival period < 3 years;
- •no prior anti-tumor therapy;
- •have signed informed consent before the beginning of treatment.
排除标准
- •patients can not bear surgical procedure;
- •pregnant or lactating women;
- •previous cytotoxic chemotherapy, radiotherapy or immunotherapy;
- •with peritoneal metastasis or distant metastasis;
- •history of another malignancy within the last five years;
- •history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake;
- •clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months;
- •organ allografts requiring immunosuppressive therapy;
- •serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease;
- •moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN);
- •hypersensitivity to any drug of the study regimen;
- •unwilling or unable to comply with the protocol for the duration of the study.
研究组 & 干预措施
SEEOX group
A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy.
干预措施: oxaliplatin (Drug)
SEEOX group
A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy.
干预措施: etoposide (Drug)
SEEOX group
A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy.
干预措施: epirubicin (Drug)
SEEOX group
A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy.
干预措施: S1 (Drug)
结局指标
主要结局
2-year survival rate
时间窗: up to 4 years
次要结局
- Operative mortality rate(up to 2 years)
- in-hospital mortality rate(up to 2 years)
- Overall response rate(up to 2 years)
- R0 resection rate(up to 2 years)
研究者
Li Guoli
Professor
Jinling Hospital, China