Clinical trial: Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer (NCT02426034)

Eligibility criteria:
Inclusion Criteria:

          1. Age: 18 to75 years old;

          2. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the
             gastroesophageal junction) with measurable metastases outside the stomach (measuring ≥
             10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);

          3. Failure of prior therapy (during or after treatment) in patients who have received at
             least two prior chemotherapy regimens;

          4. ECOG PS of 0-2;

          5. Major organ function has to meet the following criteria:

             For results of blood routine test (without blood transfusion within 14 days):

               -  HB ≥ 90g / L

               -  ANC ≥ 1.5 × 109 / L

               -  PLT ≥ 80 × 109 / L

             Biochemical tests results:

               -  Bilirubin <1.25 times the upper limit of normal (ULN)

               -  ALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN

               -  Serum Cr ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault
                  formula)

          6. An expected survival of ≥ 3 months;

          7. Patient received apatinib treatment regimen at investigators' discretion;

          8. Patient has to voluntarily join the study and sign the Informed Consent Form for the
             study;

          9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age
             within 7 days before enrolment and the test result must be negative. They shall take
             appropriate methods for contraception during the study until the 8th week post the
             last administration of study drug. For men, (previous surgical sterilization
             accepted), shall agree to take appropriate methods of contraception during the study
             until the 8th week post the last administration of study drug.

        Exclusion Criteria:

          1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg
             and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary
             heart disease greater than ClassII; II-level arrhythmia (including QT interval
             prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiac
             dysfunction;

          2. Factors that could have an effect on oral medication (such as inability to swallow,
             chronic diarrhea and intestinal obstruction);

          3. Subjects with high gastrointestinal bleeding risk, including the following conditions:
             local active ulcer lesions with positive fecal occult blood test (++); history of
             black stool, or vomiting blood in the past 3 months;unresected primary lesion in
             stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with
             massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy
             result;

          4. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;

          5. Associated with CNS (central nervous system) metastases;

          6. Pregnant or lactating women;

          7. Other conditions regimented at investigators' discretion.
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? Entailment