Clinical trial NCT03355612: XELOX Plus Apatinib vs XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Gastric Carcinoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease Free Survival(DFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 8 years
measure: Percentage of Participants With Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Han Liang, Master
role: STUDY_CHAIR
References: