Clinical trial NCT02380131: Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
Official title: Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HER-2 Positive Gastric Cancer
Liver Metastasis
Keywords: XELOX
Herceptin
Potentially Resectable Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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: The number of Participants with 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: Qun Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: