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

Liver Metastasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02380131
• Other study ID #: Alien-Craft 0002
• Status: Recruiting
• Phase: Phase 4
• First received: October 8, 2013
• Last updated: March 4, 2015
• Start date: February 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2015
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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;

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HER-2 Positive Gastric Cancer
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin plus Capecitabine
A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk?valuation for every two cycles.
• Herceptin
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.

Locations

Country	Name	City	State
China	Department of Internal Medicine-Oncology	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	R0-resection rate		within 3 weeks after surgery	No
Other	Overall survival (OS)		2 years	No
Other	The number of Participants with adverse events	Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0.	2 years	Yes
Primary	progression-free survival(PFS)		2 years	No
Secondary	Objective response rate (ORR)		within 3 weeks after surgery	No