Clinical trial: Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma (NCT02370849)

Eligibility criteria:
Inclusion Criteria:

          1. provision of written informed consent;

          2. male or female; and aged ≥ 18 years;

          3. Histologically verified, untreated, metastatic or locally advanced inoperable
             adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal
             junction;

          4. At least one radiographically documented measurable lesion according to Response
             Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria;

          5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life
             expectancy ≥ 3months;

          6. No previous palliative chemotherapy;

          7. Adequate function of vital organs: white blood cells (WBC) ≥ 4.0×109/L, neutrophils
             (ANA) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90g/L (blood transfusion is
             permitted if necessary), serum bilirubin ≤ 1 times the upper normal limit (UNL),
             aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the
             UNL, alkaline phosphatase (AKP) ≤ 5 times the UNL, creatinine (Cr) ≤ 1 times the UNL,
             normal electrocardiography (ECG).

        Exclusion Criteria:

          1. pregnant or lactating patients, or reproductive women without effective contraception;

          2. Patients with only non-measurable disease: small lesions (longest diameter < 10mm or
             pathological lymph nodes with ≥ 10 to < 15mm short axis), Bone lesions, leptomeningeal
             disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or
             lung; abdominal masses/abdominal organomegaly identified by physical exam that is not
             measurable by reproducible imaging techniques.

          3. Symptomatic of brain metastasis;

          4. Patients with clinically severe comorbidity including diabetes mellitus, hypertension,
             heart disease, or chronic active hepatitis (HBV carrier can be enrolled if
             circumstance permits );

          5. No previous radiotherapy for measurable lesions.
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.


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