Clinical trial: Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer (NCT02537171)

Eligibility criteria:
Inclusion Criteria:

          1. Age≥18 years;

          2. Pathologically diagnosed with advanced gastric adenocarcinoma (including
             gastroesophageal junction) with measurable metastases outside the stomach (≥10mm on
             spiral CT scan, and meet the criteria of Response Evaluation Criteria in Solid Tumors
             1.1);

          3. Locally advanced, recurrent or metastatic gastric or gastro-oesophageal junction
             adenocarcinoma;

          4. Finished first-line chemotherapy (fluorouracil combined with oxaliplatin, cisplatin,
             paclitaxel or docetaxel) 3 weeks a cycle for 4 cycles, of which the last efficacy
             assessment is SD, PR or CR. No more than 28 days from the starting day of last cycle
             of chemotherapy;

          5. Eastern Cooperative Oncology Group（ECOG）performance status 0 or 1;

          6. Blood routine test and Biochemical tests:

               -  Hemoglobin ≥ 80g / L;

               -  Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;

               -  Platelet count≥ 90 × 109 / L;

               -  Alanine aminotransferase (ALT)and Aspartate aminotransferase (AST) <2.5× upper
                  limit of normal (ULN); liver metastases, if any, the ALT and AST<5 × ULN;

               -  Serum total bilirubin≤1.5 × ULN;

               -  Serum creatinine≤1.5 × ULN;

               -  Serum albumin≥30g/L;

          7. Life expectancy more than 3 months;

          8. 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. Patients with a known history of allergic reactions and/or hypersensitivity attributed
             to apatinib or its accessories;

          2. 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 ClassⅠ; Ⅰ-level arrhythmia (including QT interval
             prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰcardiac
             dysfunction; Patients with positive urinary protein;

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

          4. 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 haematemesis in the past 2 months;primary lesion in stomach with
             positive fecal occult blood test (+) should be evaluated by endoscopy and other
             potential massive haemorrhage conditions evaluated by the investigator;

          5. Abnormal Coagulation (international normalized ratio>1.5, activated partial
             thromboplastin time>1.5 UNL), with tendency of bleeding;

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

          7. Pregnant or lactating women;

          8. Suffering from other malignancies within 5 years;

          9. History of uncontrolled psychotropic drug abuse or mental disorders;

         10. Participated in other clinical study within 4 weeks;

         11. Prior VEGFR inhibitor treatment,such as sorafenib and sunitinib ;

         12. Concomitant disease conditions judged by investigator that may seriously affect
             subject's safety or affect the study completion;

         13. Other cases that the researcher found ineligible
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