Status:
UNKNOWN
T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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.
Detailed Description
Gastric cancer is the second leading cause of cancer death worldwide. Highest incidence rate is observed in Eastern Asia. D2 gastrectomy has been established as a standard surgical procedure. While r...
Eligibility Criteria
Inclusion
- Signed informed-consent form.
- Aged 18-80 years.
- Had partial or total D2 gastrectomy and achieved R0 resection.
- Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma
- Pathologic Stage III (IIIA-C).
- HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).
- Patients must have received no preoperative chemotherapy or radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .
- Adequate liver/bone marrow function.Blood and biochemical parameters;
- Compliant, and can be followed up regularly.
Exclusion
- Patients who do not meet the Inclusion Criteria.
- Pregnant or breast-feeding female, or not willing to take contraception measures during study.
- Serious infection requiring antibiotics intervention during recruitment.
- Allergic to study drug or with metabolism disorder.
- Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others.
- Uncontrolled brain metastasis or mental illness.
- Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included).
- Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
- With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc.
- with other malignant tumors.
- Can be followed up or obey protocol.
- Ineligible by the discretion of the investigator.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02250209
Start Date
July 1 2014
End Date
December 1 2017
Last Update
September 26 2014
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853