Gastric Cancer, Liver Metastasis
Conditions
Keywords
Capecitabine, Oxaliplatin, Bevacizumab, Potentially Resectable Gastric Cancer Liver Metastasis
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.
Interventions
DRUGOxaliplatin;Capecitabine
A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
DRUGOxaliplatin;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.
Sponsors
Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 H2. 5.gastric cancer were able to resectable lesions or T1-4a N1-2 M0. 6.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis. 7.Karnofsky performance status performance status \>70. 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.
Exclusion criteria
* 1\. Patients with other extrahepatic metastasis Include peritoneal metastasis. 2\. Primary was ulcerative type or the existence of the perforation. 3\. Patients with other malignancy in 5 years. 4\. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | within 3 weeks after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| R0-resection rate | within 3 weeks after surgery | — |
| Overall survival (OS) | 2 years | — |
| Adverse events | 2 years | Side effects during observation\] Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit. |
Countries
China
Outcome results
None listed