Preoperative Chemotherapy With Bevacizumab For Potentially Resectable Gastric Cancer With Liver Metastasis
NCT ID: NCT01962376
Last Updated: 2013-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2013-02-28
2015-04-30
Brief Summary
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Detailed Description
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Groups 2:Capecitabine Plus Oxaliplatin With placebo in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis.
Group 1 compare with Group 2 in disease-free survival time. Stage I：Preoperative therapy Capecitabine Plus Oxaliplatin With Bevacizumab is superior to Capecitabine Plus Oxaliplatin alines.
Stage II: therapy after surgery Capecitabine Plus Oxaliplatin With Bevacizumab is superior to Capecitabine Plus Oxaliplatin alones after surgery for over 6 months in all.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab,postoperative chemotherapy
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
Oxaliplatin;Capecitabine
A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
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.
Preoperative Chemotherapy
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
Oxaliplatin;Capecitabine
A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
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.
Interventions
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Oxaliplatin;Capecitabine
A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2.Immunohistochemistry confirmed HER-2 ( - ).
3.The number of liver metastasis is less than 3 and evey one is less than 5 cm.
4.Liver metastasis must be clinically limited to Type H1 or Type H2.
5.gastric cancer were able to resectable lesions or T1-4a N1-2 M0.
6.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
7.Karnofsky performance status performance status \>70.
8.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3
9.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.
10.expectancy must be more than 3 months.
11.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.
12.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.
Exclusion Criteria
2\. Primary was ulcerative type or the existence of the perforation.
3\. Patients with other malignancy in 5 years.
4\. Patients with severe liver disease, kidney disease, respiratory disease , uncontrolled diabetes or severe infections.
5.Patients with hypertension failed to control, active bleeding, 3\~4 proteinuria, heal the wound, thromboembolisms, 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.
18 Years
75 Years
ALL
No
Sponsors
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Hebei Medical University
OTHER
Responsible Party
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Yan Zhang
The first hospital of Shijiazhuang city
Principal Investigators
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Yan Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University
Locations
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Department of Internal Medicine-Oncology
Shijiazhuang, Hebei, China
Countries
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Facility Contacts
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Yan Zhang, Doctor
Role: primary
Other Identifiers
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YZHANG0001
Identifier Type: -
Identifier Source: org_study_id