Clinical trial: Clinical Trial of Apatinib Reverses Chemotherapy-Resistance of Patients With Advanced Gastric Cancer (NCT02697838)

Eligibility criteria:
Inclusion Criteria:

          1. Age: more than 18 years old;

          2. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)
             , including adenocarcinoma of the gastroesophageal junction;

          3. At least one measurable and evaluable disease based on response evaluation criteria in
             solid tumors (RECIST v1.1);

          4. The patient with Prior Paclitaxel-Resistant;

          5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2;

          6. An expected survival of ≥ 3 months;

          7. Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More
             than 4 weeks for other cytotoxic agents, operation or radiotherapy;

          8. Major organ function has to meet the following criteria; (1) For results of blood
             routine test:

               1. Hemoglobin (HB) ≥ 80g / L,

               2. ANC ≥ 1.5 × 109 / L,

               3. PLT ≥ 75 × 109 / L, (2) For results of biochemical tests:

               1. BLT ≤ 1.25 times the upper limit of normal (ULN),

               2. ALT and AST ≤ 2.5 × ULN, liver metastases, if any, the ALT and AST≤ 5 × ULN,

               3. Serum Cr≤1ULN, Endogenous creatinine clearance rate >50ml/min;

          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;

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

        Exclusion Criteria:

          1. History of other malignancies except cured basal cell carcinoma of skin and carcinoma
             insitu of uterine cervix;

          2. Confirmed that apatinib and/or its accessories allergy;

          3. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg
             and diastolic blood pressure > 90 mm Hg) despite standard medical management;

          4. Serious cardiovascular disease: Ⅱ-level myocardial ischemia or myocardial infarction,
             arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms);
             III ~ IV level cardiac function insufficiency, or echocardiography showed that left
             ventricular ejection fraction (LVEF < 50%);

          5. Patients with positive urinary protein (urine protein detection of 2 or more, or 24
             hour urine protein >1.0g);

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

          7. 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 2 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;

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

          9. With psychotropic drug abuse history and can't get rid or with mental disorder
             patients;

         10. Less than 4 weeks from the last clinical trial;

         11. According to the researcher's judgment, with other serious diseases which harm to
             patient safety or affect patients complete the study;

         12. Evidence of central nervous system(CNS) metastasis;

         13. Pregnant or lactating women;

         14. 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.


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