Gastric Carcinoma
Conditions
Brief summary
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
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.
Interventions
DRUGApatinib
Apatinib: 500 mg, qd, po, last 180 days
DRUGXELOX
Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival(DFS) | 5 years | Disease Free Survivalof the Participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | 8 years | Overall Survival of the Participants |
| Percentage of Participants With Adverse Events | 5 years | Percentage of Participants With Adverse Events |
Contacts
Primary ContactHan Liang, Master
Backup ContactMingzhi Cai, Master
Outcome results
None listed