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

NCT02380131 | Unknown Phase 4

• 1 other identifier: Alien-Craft 0002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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;

Conditions

HER-2 Positive Gastric Cancer; Liver Metastasis

Keywords

XELOX; Herceptin; Potentially Resectable Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival(PFS)

  2 years

Secondary Outcomes (1)

• Objective response rate (ORR)

  within 3 weeks after surgery

Other Outcomes (3)

• R0-resection rate

  within 3 weeks after surgery

• Overall survival (OS)

  2 years

• The number of Participants with adverse events

  2 years

Study Arms (1)

Herceptin

EXPERIMENTAL

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; Drug: Herceptin

Interventions

Oxaliplatin plus Capecitabine DRUG

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

Also known as: Oxaliplatin plus capecitabine other names:XELOX.

Herceptin

Herceptin 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.

Also known as: Trastuzumab

Herceptin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological tissue were gastric cancer by gastric and liver biopsy.
• Immunohistochemistry confirmed HER-2 (+)or FISH(+).
• gastric cancer with liver metastasis were not able to resectable lesions.
• Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
• ECOG performance status 0-1.
• 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.
• 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.
• Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.
• The operation can complete the D2 operation(LNM≥15).
• LVEF≥50%

You may not qualify if:

• \. Patients with other extrahepatic metastasis Include peritoneal metastasis.
• \. Patients with other malignancy in 5 years.
• \. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.
• Patients with hypertension failed to control, active bleeding, 3\~4 proteinuria, heal the wound, romboembolism, heart failure, clinical symptoms of heart disease.
• Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.
• Patients have history of organ transplantation.
• 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.
• Patients combined antitumor drug outside the research program.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

Department of Internal Medicine-Oncology

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Capecitabine; Trastuzumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Qun Zhao, Doctor

  Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: March 5, 2015
• Study Start: February 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 5, 2015

Record last verified: 2015-02

Locations

CN (1)