HER-2 Positive Gastric Cancer, Liver Metastasis
Conditions
Keywords
XELOX, Herceptin, Potentially Resectable Gastric Cancer
Brief summary
Stage I：preoperative therapy * Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy * Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;
Detailed description
The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.
Interventions
A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.
DRUGHerceptin
Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles.
Sponsors
Hebei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 (+)or FISH(+). 3.gastric cancer with liver metastasis were not able to resectable lesions. 4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis. 5.ECOG performance status 0-1. 6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 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≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L. 8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days. 10.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later. 11.The operation can complete the D2 operation(LNM≥15). 12.LVEF≥50%
Exclusion criteria
* 1\. Patients with other extrahepatic metastasis Include peritoneal metastasis. 3\. Patients with other malignancy in 5 years. 4\. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome. 5.Patients with hypertension failed to control, active bleeding, 3\ 4 proteinuria, heal the wound, romboembolism, 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 | — |
| The number of Participants with adverse events | 2 years | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. |
Countries
China
Outcome results
None listed