Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis
Overview
- Phase
- Phase 4
- Intervention
- Oxaliplatin;Capecitabine
- Conditions
- Gastric Cancer
- Sponsor
- Hebei Medical University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- progression-free survival(PFS)
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Yan Zhang
The first hospital of Shijiazhuang city
Hebei Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Oxaliplatin;Capecitabine
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
Intervention: Oxaliplatin;Capecitabine;Bevacizumab
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
Intervention: Oxaliplatin;Capecitabine
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
Intervention: Oxaliplatin;Capecitabine;Bevacizumab
Outcomes
Primary Outcomes
progression-free survival(PFS)
Time Frame: 2 years
Secondary Outcomes
- Objective response rate (ORR)(within 3 weeks after surgery)