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

Phase 4

• Conditions: HER-2 Positive Gastric Cancer; Liver Metastasis
• Interventions: Drug: Oxaliplatin plus Capecitabine; Drug: Herceptin

• Registration Number: NCT02380131
• Lead Sponsor: Hebei Medical University

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-10-08
• Status Verified: 2015-02
• Study First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

  2. Patients with other malignancy in 5 years.

  3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Herceptin	Oxaliplatin plus Capecitabine	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
Herceptin	Herceptin	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

Primary Outcome Measures

Name	Time	Method
progression-free survival(PFS)	2 years

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	within 3 weeks after surgery

Trial Locations

Locations (1)

Department of Internal Medicine-Oncology; 🇨🇳 Shijiazhuang, Hebei, China