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

November 22, 2017 updated by: Tianjin Medical University Cancer Institute and Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 5 years
Disease Free Survivalof the Participants
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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