Clinical trial: T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy (NCT02250209)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment