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

Gastric Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03355612
• Other study ID #: RESAPAS Trial
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 22, 2017
• Last updated: November 22, 2017
• Start date: December 20, 2017
• Est. completion date: December 20, 2025

Study information

• Verified date: November 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Han Liang, Master
• Phone: (022)23340123
• Email: tjlianghan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 456
• Est. completion date: December 20, 2025
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• Apatinib
Apatinib: 500 mg, qd, po, last 180 days
• XELOX
Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival(DFS)	Disease Free Survivalof the Participants	5 years
Secondary	Overall Survival(OS)	Overall Survival of the Participants	8 years
Secondary	Percentage of Participants With Adverse Events	Percentage of Participants With Adverse Events	5 years