Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- progression-free survival(PFS)
研究概览
简要总结
The investigators assessed whether the addition of a preoperative regimen of Bevacizumab regimen to improves R0 resection rate and survival among patients with potentially resectable gastric cancer with liver metastasis.
详细描述
Groups 1:Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis.
Groups 2:Capecitabine Plus Oxaliplatin With placebo in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis.
Group 1 compare with Group 2 in disease-free survival time. Stage I：Preoperative therapy Capecitabine Plus Oxaliplatin With Bevacizumab is superior to Capecitabine Plus Oxaliplatin alines.
Stage II: therapy after surgery Capecitabine Plus Oxaliplatin With Bevacizumab is superior to Capecitabine Plus Oxaliplatin alones after surgery for over 6 months in all.
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
- •1.Pathological tissue were gastric cancer by gastric and liver biopsy.
- •2.Immunohistochemistry confirmed HER-2 ( - ).
- •3.The number of liver metastasis is less than 3 and evey one is less than 5 cm.
- •4.Liver metastasis must be clinically limited to Type H1 or Type H
- •5.gastric cancer were able to resectable lesions or T1-4a N1-2 M
- •6.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
- •7.Karnofsky performance status performance status >
- •8.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3
- •9.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN);alanine transaminase / Aspertate aminotransferase≤2.5 upper limit of normal range (ULN) (≤5.0 x ULN if hepatic metastasis); serum creatinine≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L.
- •10.expectancy must be more than 3 months.
- •11.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.
- •12.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.
- •Type H1: only one leaf with liver metastasis. Type H2: two leaves with a few scattered metastatic in liver.
排除标准
- •Patients with other extrahepatic metastasis Include peritoneal metastasis.
- •Primary was ulcerative type or the existence of the perforation.
- •Patients with other malignancy in 5 years.
- •Patients with severe liver disease, kidney disease, respiratory disease , uncontrolled diabetes or severe infections.
- •5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, thromboembolisms, heart failure, clinical symptoms of heart disease.
- •6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.
- •7.Patients have history of organ transplantation.
- •8.Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
- •9.Patients combined antitumor drug outside the research program.
研究组 & 干预措施
Bevacizumab,postoperative chemotherapy
Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.
Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
placebo:Physiological saline
干预措施: Oxaliplatin;Capecitabine (Drug)
Bevacizumab,postoperative chemotherapy
Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.
Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
placebo:Physiological saline
干预措施: Oxaliplatin;Capecitabine;Bevacizumab (Drug)
Preoperative Chemotherapy
Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.
Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.placebo:Physiological saline
干预措施: Oxaliplatin;Capecitabine (Drug)
Preoperative Chemotherapy
Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.
Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.placebo:Physiological saline
干预措施: Oxaliplatin;Capecitabine;Bevacizumab (Drug)
结局指标
主要结局
progression-free survival(PFS)
时间窗: 2 years
次要结局
- Objective response rate (ORR)(within 3 weeks after surgery)
研究者
Yan Zhang
The first hospital of Shijiazhuang city
Hebei Medical University