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

Study Overview
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Brief Summary
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This is a randomized, multicenter, controlled study to compared the Efficacy and Safety of XELOX combined with Apatinib versus XELOX as post-operative chemotherapy in locally advanced gastric signet ring carcinoma with D2 dissection.

Detailed Description
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The purpose of this study is to prove that as for disease free survival time, and safety, Apatinib with XELOX(Oxaliplatin with Capecitabine) has a better effect over that of XELOX adjunct therapy group for postoperative chemotherapy of locally advanced gastric signet ring carcinoma with D2 dissection.

Official Title
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A Randomized, Multicenter, Controlled Study of XELOX (Oxaliplatin With Capecitabine) Combined With Apatinib Versus XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma With D2 Dissection.

Conditions
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Gastric Carcinoma

Intervention / Treatment
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* Drug: Apatinib
* Drug: XELOX


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin) | Drug: Apatinib<br>* Apatinib: 500 mg, qd, po, last 180 days<br>* Other names: YN968D1;Drug: XELOX<br>* Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w<br>* Other names: Capecitabine and Oxaliplatin;|
| Active Comparator: active comparator<br>Drug:XELOX(Capecitabine and Oxaliplatin) | Drug: XELOX<br>* Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w<br>* Other names: Capecitabine and Oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival(DFS) | Disease Free Survivalof the Participants | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | Overall Survival of the Participants | 8 years | 
| Percentage of Participants With Adverse Events | Percentage of Participants With Adverse Events | 5 years |