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

NCT ID: NCT02380131

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

HER-2 Positive Gastric Cancer; Liver Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Oxaliplatin plus Capecitabine

Intervention Type: DRUG

A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.

Herceptin

Intervention Type: DRUG

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.

Interventions

Oxaliplatin plus Capecitabine

A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.

Intervention Type: DRUG

Herceptin

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.

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin plus capecitabine other names:XELOX.; Trastuzumab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qun Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University

Locations

Department of Internal Medicine-Oncology

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qun Zhao, Doctor

Role: primary

zhaoqun516@126.com

+8613930162111

Other Identifiers

Alien-Craft 0002

Identifier Type: -

Identifier Source: org_study_id