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

NCT ID: NCT03355612

Last Updated: 2017-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2025-12-20

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.

Conditions

Gastric Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin)

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib: 500 mg, qd, po, last 180 days

XELOX

Intervention Type: DRUG

Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w

active comparator

Drug:XELOX(Capecitabine and Oxaliplatin)

Group Type: ACTIVE_COMPARATOR

XELOX

Intervention Type: DRUG

Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w

Interventions

Apatinib

Apatinib: 500 mg, qd, po, last 180 days

Intervention Type: DRUG

XELOX

Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w

Intervention Type: DRUG

Other Intervention Names

YN968D1; Capecitabine and Oxaliplatin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Han Liang, Master

Role: STUDY_CHAIR

Tianjin Medical University Cancer Institute and Hospital

Central Contacts

Han Liang, Master

Role: CONTACT

Phone: （022）23340123

Email: tjlianghan@126.com

Mingzhi Cai, Master

Role: CONTACT

Phone: 13821389052

Email: tsaimingzhi@163.com

Other Identifiers

RESAPAS Trial

Identifier Type: -

Identifier Source: org_study_id