Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03598348
• Other study ID #: TJCC006
• Status: Recruiting
• Phase: Phase 3
• Start date: January 16, 2018
• Est. completion date: October 16, 2020

Study information

• Verified date: July 2018
• Source: Huazhong University of Science and Technology
• Contact: Xianglin Yuan, PhD,MD
• Phone: 8627-83663406
• Email: xlyuan1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: October 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. aged 18-75;

2. had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction;

3. received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);

4. ECOG 0-2;

5. Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease;

6. presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines;

7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;

8. Adequate organ function as defined below: Hematologic ANC = 2*109/L, Platelets = 100*109/L, AST and ALT = 2.5×ULN, TBIL = 1.5×ULN

9. Receiving no form of chemotherapy, targeted therapy or other study medication;

Exclusion Criteria:

1. previous radiotherapy to the abdomen;

2. previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered >6 months before enrollment);

3. pregnant or lactating women or women of childbearing potential;

4. disease progression during the first-line chemotherapy;

5. active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment

6. previous treatment of apatinib and Ramucirumab

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Apatinib+Capecitabine
Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
• Apatinib
Apatinib 250mg po Qd

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	36 months
Secondary	OS	From date of randomization until the date of first documented death from any cause, assessed up to 36 months	36 months