Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer
NCT ID: NCT03598348
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
288 participants
INTERVENTIONAL
2018-01-16
2020-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Maintenance Treatment Group A
Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
Apatinib+Capecitabine
Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
Observation Group
Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
No interventions assigned to this group
Maintenance Treatment Group B
Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
Apatinib
Apatinib 250mg po Qd
Interventions
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Apatinib+Capecitabine
Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
Apatinib
Apatinib 250mg po Qd
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Xianglin Yuan
Professor, Chief physician
Principal Investigators
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Xianglin Yuan, PhD,MD
Role: STUDY_CHAIR
Tongji Hospital
Locations
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Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TJCC006
Identifier Type: -
Identifier Source: org_study_id
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