Preoperative Chemotherapy With Bevacizumab For Potentially Resectable Gastric Cancer With Liver Metastasis

NCT01962376 | Unknown Phase 4

• 1 other identifier: YZHANG0001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators assessed whether the addition of a preoperative regimen of Bevacizumab regimen to improves R0 resection rate and survival among patients with potentially resectable gastric cancer with liver metastasis.

Conditions

Gastric Cancer; Liver Metastasis

Keywords

Capecitabine; Oxaliplatin; Bevacizumab; Potentially Resectable Gastric Cancer Liver Metastasis

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

• Adverse events

  2 years

Study Arms (2)

Bevacizumab,postoperative chemotherapy

ACTIVE COMPARATOR

Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles. Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles. placebo:Physiological saline

Drug: Oxaliplatin;Capecitabine; Drug: Oxaliplatin;Capecitabine;Bevacizumab

Preoperative Chemotherapy

EXPERIMENTAL

Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles. Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.placebo:Physiological saline

Drug: Oxaliplatin;Capecitabine; Drug: Oxaliplatin;Capecitabine;Bevacizumab

Interventions

Oxaliplatin;Capecitabine DRUG

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

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

Bevacizumab,postoperative chemotherapy; Preoperative Chemotherapy

Oxaliplatin;Capecitabine;Bevacizumab DRUG

A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.

Also known as: Capecitabine Plus Oxaliplatin Other names XELOX.

Bevacizumab,postoperative chemotherapy; Preoperative Chemotherapy

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 ( - ).
• The number of liver metastasis is less than 3 and evey one is less than 5 cm.
• Liver metastasis must be clinically limited to Type H1 or Type H2.
• gastric cancer were able to resectable lesions or T1-4a N1-2 M0.
• Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
• Karnofsky performance status performance status \>70.
• Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3
• Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN);alanine transaminase / Aspertate aminotransferase≤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.
• 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.
• Type H1: only one leaf with liver metastasis. Type H2: two leaves with a few scattered metastatic in liver.

You may not qualify if:

• \. Patients with other extrahepatic metastasis Include peritoneal metastasis.
• \. Primary was ulcerative type or the existence of the perforation.
• \. Patients with other malignancy in 5 years.
• \. Patients with severe liver disease, kidney disease, respiratory disease , uncontrolled diabetes or severe infections.
• Patients with hypertension failed to control, active bleeding, 3\~4 proteinuria, heal the wound, thromboembolisms, 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

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

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

Study Officials

• Yan Zhang, Doctor

  Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The first hospital of Shijiazhuang city

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 14, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

CN (1)