Clinical trial: S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients (NCT01824459)

Eligibility criteria:
Inclusion Criteria:

          1. histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-type
             gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

          2. 18 years old to 75 years old, able to conduct oral administration.

          3. Measurable disease or non-measurable but evaluable disease, according to the Response
             Evaluation Criteria in Solid Tumours(RECIST 1.1)

          4. No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant
             chemotherapy , if applicable, more than 12 months.

          5. ECOG systemic status score of 0 to 2.

          6. normal organ function, that meet the following criteria:

               1. ALT and AST(≤2.5 times ULN (≤5 times ULN in patients with liver metastases)

               2. ALP ≤ 2 times ULN ; (for patients with liver metastases can be no limit to the
                  ALP).

               3. Total bilirubin ≤ 1 times ULN.

               4. Absolute neutrophil count ≥ 2.0 × 10^9 / L.

               5. Platelet count ≥ 100 × 10^9 / L.

               6. Hemoglobin ≥ 80g / L.

               7. Creatinine ≤ 1.25 times ULN.

               8. The estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula).

          7. Signed informed consent, treatment, follow-up and inspection in accordance with the
             study protocol.

          8. Life expectancy greater than 3 months.

          9. At least 3 weeks after major surgery.

        Exclusion Criteria:

          1. Previous adjuvant or neoadjuvant chemotherapy within the prescribed time

          2. the investigator determines that the patient is not suitable for participation in this
             study, and specifically includes (but is not limited to):

               1. The past five years there have been other malignancies, but after appropriate
                  treatment of cervical carcinoma in situ and non-melanoma skin cancer.

               2. brain metastases or leptomeningeal metastasis.

               3. myocardial infarction (within the past six months), severe unstable angina,
                  congestive heart failure.

               4. Serious complications (including paralytic ileus, intestinal obstruction,
                  interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renal
                  insufficiency and cirrhosis of the liver, etc.).

               5. Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 times
                  or watery stools).

               6. Gastrointestinal bleeding, and need for frequent blood transfusions.

               7. human immunodeficiency virus (HIV) carrier or suffering from AIDS (AIDS).

               8. Suffering from a mental illness.

               9. neuropathy severity ≥grade 2 .

              10. Infectious disease or inflammation, body temperature ≥ 38 ℃.

          3. Cisplatin, oxaliplatin, or S-1 allergy.

          4. Pregnancy or breast-feeding women.

          5. refused to take appropriate contraceptive measures (including male patients).

          6. Under experimental drug within 4 weeks.

          7. Under other anti-cancer treatment.

          8. HER2 IHC(3+) or IHC(2+) /FISH(+)
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 75 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? 1