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

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03355612

Collaborator

(none)

456

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Carcinoma	Drug: Apatinib Drug: XELOX	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

456 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Dec 20, 2017

Anticipated Primary Completion Date :

Dec 20, 2020

Anticipated Study Completion Date :

Dec 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin)	Drug: Apatinib Apatinib: 500 mg, qd, po, last 180 days Other Names: YN968D1 Drug: XELOX Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w Other Names: Capecitabine and Oxaliplatin
Active Comparator: active comparator Drug:XELOX(Capecitabine and Oxaliplatin)	Drug: XELOX Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w Other Names: Capecitabine and Oxaliplatin

Arm

Intervention/Treatment

Experimental: experimental group

Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin)

Drug: Apatinib

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

Other Names:

YN968D1

Drug: XELOX

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

Other Names:

Capecitabine and Oxaliplatin

Active Comparator: active comparator

Drug:XELOX(Capecitabine and Oxaliplatin)

Drug: XELOX

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

Other Names:

Capecitabine and Oxaliplatin

Outcome Measures

Primary Outcome Measures

Disease Free Survival(DFS) [5 years]
Disease Free Survivalof the Participants

Secondary Outcome Measures

Overall Survival(OS) [8 years]
Overall Survival of the Participants
Percentage of Participants With Adverse Events [5 years]
Percentage of Participants With Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. ≥ 18 and ≤ 70 years of age;
1. Eastern Cooperative Oncology Group Performance Status: 0-1;
1. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
1. Postoperative histological proven gastric signet-ring cell carcinoma(or contains signet-ring cell carcinoma);
1. Pathological stage:IIIA-IIIC（8th AJCC TNM）;
1. 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;
1. The ECG(electrocardiography) was basically normal in the 4 weeks before the study, and there was no obvious clinical symptoms of heart disease;
1. sign informed consent.

Exclusion Criteria:

1. Patients with hypertension and uncontrolled hypertension with hypotensive drugs therapy ;
1. Patients with dysphagia, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc;
1. Patients had bradycardia or a QT extension;
1. Patients had gastrointestinal fistula and lacerations after surgery;
1. Allergic to capecitabine or oxaliplatin, or metabolic disorders;
1. Patients accepted Preoperative chemotherapy, radiotherapy or targeted therapy;
1. Attending other drug clinical trials;
1. 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）;
1. Patients with peripheral nervous system disorder or apparent mental disorders or had the history of central nervous system disorders;
1. Patients with serious infection(above CTCAE grade 2);
1. 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 );
1. 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);
1. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
1. Patients without legal capacity,or medical/ethical reasons may influence the study to continue.