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

NCT03355612 | Unknown Phase 3

• 1 other identifier: RESAPAS Trial
• Study Type: interventional
• Target: 456
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival(DFS)

  Disease Free Survivalof the Participants

  5 years

Secondary Outcomes (2)

• Overall Survival(OS)

  8 years

• Percentage of Participants With Adverse Events

  5 years

Study Arms (2)

experimental group

EXPERIMENTAL

Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin)

Drug: Apatinib; Drug: XELOX

active comparator

ACTIVE COMPARATOR

Drug:XELOX(Capecitabine and Oxaliplatin)

Drug: XELOX

Interventions

Apatinib DRUG

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

Also known as: YN968D1

experimental group

XELOX DRUG

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

Also known as: Capecitabine and Oxaliplatin

active comparator; experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib; XELOX; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Han Liang, Master

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Han Liang, Master

CONTACT

（022）23340123; tjlianghan@126.com

Mingzhi Cai, Master

CONTACT

13821389052; tsaimingzhi@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: December 20, 2017
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2025
• Last Updated: November 28, 2017

Record last verified: 2017-11