T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Capecitabine; Oxaliplatin; Trastuzumab

Criteria

Inclusion Criteria:

1. Signed informed-consent form.

2. Aged 18-80 years.

3. Had partial or total D2 gastrectomy and achieved R0 resection.

4. Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma

5. Pathologic Stage III (IIIA-C).

6. HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).

7. Patients must have received no preoperative chemotherapy or radiation therapy.

8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .

9. Adequate liver/bone marrow function.Blood and biochemical parameters;

10. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Patients who do not meet the Inclusion Criteria.

2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.

3. Serious infection requiring antibiotics intervention during recruitment.

4. Allergic to study drug or with metabolism disorder.

5. Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others.

6. Uncontrolled brain metastasis or mental illness.

7. Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included).

8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.

9. With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc.

10. with other malignant tumors.

11. Can be followed up or obey protocol.

12. Ineligible by the discretion of the investigator.