Clinical trial NCT01962376: Preoperative Chemotherapy With Bevacizumab For Potentially Resectable Gastric Cancer With Liver Metastasis
Official title: Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastric Cancer
Liver Metastasis
Keywords: Capecitabine
Oxaliplatin
Bevacizumab
Potentially Resectable Gastric Cancer Liver Metastasis
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Groups 1:Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis.

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.

Eligibility criteria: Inclusion Criteria:

* 1.Pathological tissue were gastric cancer by gastric and liver biopsy.

  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:

* 1. Patients with other extrahepatic metastasis Include peritoneal metastasis.

  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.

Primary outcomes:
measure: progression-free survival(PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: within 3 weeks after surgery
Other outcomes:
measure: R0-resection rate
timeFrame: within 3 weeks after surgery
measure: Overall survival (OS)
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Locations:
city: Shijiazhuang
country: China
facility: Department of Internal Medicine-Oncology
state: Hebei
Study officials:
affiliation: Hebei Medical University
name: Yan Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: