Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Conditions
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HER-2 Positive Gastric Cancer, Liver Metastasis

Intervention / Treatment
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* Drug: Oxaliplatin plus Capecitabine
* Drug: Herceptin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herceptin<br>drug: Oxaliplatin;Capecitabine;Herceptin A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. 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. To explore the effect of herceptin with chemotherapy for potentially resectable HER-2 positive gastric cancer with liver metastasis | Drug: Oxaliplatin plus Capecitabine<br>* A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.<br>* Other names: Oxaliplatin plus capecitabine other names:XELOX.;Drug: Herceptin<br>* 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.<br>* Other names: Trastuzumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival(PFS) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | within 3 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XELOX, Herceptin, Potentially Resectable Gastric Cancer