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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Carcinoma
• Intervention / Treatment: Drug: XELOX; Drug: Apatinib

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 Type: Interventional
• Enrollment (Anticipated): 456
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Han Liang, Master; Phone Number: 1063 （022）23340123; Email: tjlianghan@126.com
• Study Contact Backup: Name: Mingzhi Cai, Master; Phone Number: 13821389052; Email: tsaimingzhi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Drug:Apatinib with 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; Drug: Apatinib; Apatinib: 500 mg, qd, po, last 180 days; Other Names: YN968D1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival(DFS)	Disease Free Survivalof the Participants	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival(OS)	Overall Survival of the Participants	8 years
Percentage of Participants With Adverse Events	Percentage of Participants With Adverse Events	5 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Chair: Han Liang, Master, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2017
• Primary Completion (Anticipated): December 20, 2020
• Study Completion (Anticipated): December 20, 2025

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Cystic, Mucinous, and Serous; Stomach Neoplasms; Carcinoma; Carcinoma, Signet Ring Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Capecitabine; Oxaliplatin; Apatinib
• Other Study ID Numbers: RESAPAS Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No