XELOX Plus Apatinib vs XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Nov 22, 2017

Keywords

ClinConnect Summary

This clinical trial is looking to compare two types of chemotherapy for patients with a specific kind of stomach cancer called gastric signet ring carcinoma. The researchers want to see if combining a treatment called Apatinib with standard chemotherapy (known as XELOX) is more effective than using XELOX alone after surgery. This study is for adults aged 18 to 70 who have had surgery to remove their stomach cancer and whose cancer has been confirmed by a biopsy.

To participate in this trial, patients must meet certain health criteria, such as having good overall health without serious heart or kidney problems. They should have had a specific type of surgery and their cancer must be at an advanced stage (IIIA-IIIC). If eligible, participants will receive either the combination treatment or the standard treatment and will be monitored for how well the treatment works and any side effects. This trial is not yet recruiting participants, so it's a good idea for interested individuals to stay in touch with their healthcare team for updates.

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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.