Clinical trial: Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma (NCT03788174)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with advanced unresectable, histologically confirmed adenocarcinoma of the
             gastric or gastroesophageal junction.

          -  Previous first-treatment with chemotherapy or radiation therapy failed. Ability to
             take medications orally. With measurable lesions. Patients must have a performance
             status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

          -  Without serious system dysfunction and could tolerate chemotherapy. With normal
             marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood
             transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of
             ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a
             creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min
             (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase
             (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.

          -  Life expectancy ≥3 months. With normal electrocardiogram results and no history of
             congestive heart failure.

          -  Without bleeding and thrombosis disease. With normal coagulation function: activated
             partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.

          -  Female subjects of child-bearing potential must agree to use contraceptive measures
             starting 1 week before the administration of the first dose of apatinib until 8 weeks
             after discontinuing study drug. Male subjects must agree to use contraceptive measures
             during the study and 8 weeks after last dose of study drug With written informed
             consent signed voluntarily by patients themselves or their supervisors witted by
             doctors.

          -  With good compliance and agree to accept follow-up of disease progression and adverse
             events.

        Exclusion Criteria:

          -  Patients with a history of another neoplastic disease within the past three years,
             excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or
             nonmetastatic prostate cancer.

          -  Patients with brain or central nervous system metastases, including leptomeningeal
             disease.

          -  Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound,
             ulcer, or bone fracture. Significant cardiac disease as defined as: unstable angina,
             New York Heart Association (NYHA) grade II or greater, congestive heart failure,
             history of myocardial infarction within 6 months Evidence of bleeding diathesis or
             coagulopathy.

          -  History of a stroke or CVA within 6 months. Clinically significant peripheral vascular
             disease. Inability to comply with study and/or follow-up procedures. Patients with any
             other medical condition or reason, in that investigator's opinion, makes the patient
             unstable to participate in a clinical trial.
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 70 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