A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy
NCT ID: NCT02776527
Last Updated: 2016-05-20
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
PHASE4
40 participants
INTERVENTIONAL
2016-04-30
2017-04-30
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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A group
D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox,and taking Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses.
Apatinib Mesylate Tablets
taking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses
B group
D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox
No interventions assigned to this group
Interventions
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Apatinib Mesylate Tablets
taking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Score of the Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 2.
3. All tumor tissues were histologically verified as advanced gastric cancer, and patients with no less than 15 dissected lymph nodes and stage of ⅢB or ⅢC according to TNM, were chosen.
4. Gastric cancer patients underwent the curative gastrectomy with D2 lymphadenectomy.
5. Gastric cancer patients received postoprative adjuvant chemotherapy of eight cycles of Xelox. During the period of chemotherapy, no one relapses. If the patients could well tolerate the adjuvant chemotherapy, it is recommended that patients can obtain maintenance treatment of Apatinib after postoprative adjuvant chemotherapy of eight cycles of Xelox.
6. Previously, patients did not receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.
7. The blood examination is normal: neutrophil count≥1.5×109/L；hemoglobin≥80 g/L；blood platelet count≥100×109/L；total bilirubin≤1.5×ULN；ALT、AST≤2.5×ULN；
8. Patients have no serious heart, lung, liver, kidney diseases and jaundice and digestive tract obstruction. Patients have no an acute infection.
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Exclusion Criteria
2. Previously, patients received neoadjuvant chemotherapy.
3. Within six months, patients encountered heart cerebral disease, got an uncontrolled hypertension (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg), had serious coronary heart disease, serious arrhythmia, first-grade cardiac insufficiency. Patients have positive urinary protein.
4. Patients have clear gastrointestinal bleeding tendency, local active ulcer lesions, fecal occult blood (++); Patients have the symptoms of melena and haematemesis within 2 months.
5. Coagulopathy (INR\>1.5、APTT\>1.5 ULN), hemorrhage tendency.
6. Patients have these symptoms, such as dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction.
7. Patients have these symptoms, such as neurological diseases, mental illness, serious infection.
8. Patients were pregnant, in nursing, or have bearing requirement during the study period.
9. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years.
10. Patients have distant metastasis.
11. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
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18 Years
75 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Han Liang, Master
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Hospital
Locations
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Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHEAD-HBG001
Identifier Type: -
Identifier Source: org_study_id
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