Clinical trial: XELOX Plus Apatinib vs XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma (NCT03355612)

Eligibility criteria:
Inclusion Criteria:

          -  1. ≥ 18 and ≤ 70 years of age;

          -  2. Eastern Cooperative Oncology Group Performance Status: 0-1;

          -  3. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);

          -  4. Postoperative histological proven gastric signet-ring cell carcinoma(or contains
             signet-ring cell carcinoma);

          -  5. Pathological stage:IIIA-IIIC（8th AJCC TNM）;

          -  6. Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL;
             absolute neutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total
             bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombin
             time-international normalized ratio≤1.5, and APTT(activated partial thromboplastin
             time) was within normal range; creatine ≤ 1.5 x ULN;

          -  7. The ECG(electrocardiography) was basically normal in the 4 weeks before the study,
             and there was no obvious clinical symptoms of heart disease;

          -  8. sign informed consent.

        Exclusion Criteria:

          -  1. Patients with hypertension and uncontrolled hypertension with hypotensive drugs
             therapy ;

          -  2. Patients with dysphagia, complete or incomplete digestive tract obstruction,
             gastrointestinal bleeding, perforation, etc;

          -  3. Patients had bradycardia or a QT extension;

          -  4. Patients had gastrointestinal fistula and lacerations after surgery;

          -  5. Allergic to capecitabine or oxaliplatin, or metabolic disorders;

          -  6. Patients accepted Preoperative chemotherapy, radiotherapy or targeted therapy;

          -  7. Attending other drug clinical trials;

          -  8. Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease,
             respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic
             diseases, heart disease with Clinical symptoms（such as congestive heart failure,
             coronary heart disease symptoms, drug is difficult to control arrhythmia,
             hypertension, or six months had a myocardial infarction attack, or cardiac
             insufficiency）;

          -  9. Patients with peripheral nervous system disorder or apparent mental disorders or
             had the history of central nervous system disorders;

          -  10. Patients with serious infection(above CTCAE grade 2);

          -  11. Patient with history of another malignant cancer within past 5 years（not
             including: cervical carcinoma in situ, non melanoma skin cancer and superficial
             bladder tumor );

          -  12. Have the history of organ transplantation, Or have received systemic steroid
             therapy for a long time (note: short term user stopping medication >2 weeks can be
             included);

          -  13. Pregnant or lactating women, women of child-bearing potential, unwilling to use
             adequate contraceptive protection during the process of the study;

          -  14. Patients without legal capacity,or medical/ethical reasons may influence the study
             to continue.
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? 1