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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The purpose of this study is to assess the efficacy and safety of apatinib as maintenance therapy after adjuvant chemotherapy in progressive gastric cancer patients with positive exfoliative cancer cells.
Eligible patients will recieve apatinib treatment(500mg qd p.o. q28d) for 6 cycles after 8 cycles of XELOX adjuvant chemotherapy or only XELOX adjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib Maintenance Therapy After Adjuvant Chemotherapy | Experimental | Apatinib Mesylate Tablets 500 mg qd p.o. after XELOX Adjuvant Chemotherapy (Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d) |
|
| Only Adjuvant Chemotherapy | No Intervention | No Intervention After XELOX Adjuvant Chemotherapy (Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib Mesylate Tablets 500 mg qd p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | An expected average of 2 years |
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Inclusion Criteria:
Age: 18 to75 years old;
ECOG PS of 0-1;
Histologically proven gastric cancer of stageⅡA, ⅡB, ⅢA, ⅢB and ⅢC (except level 3 or 4 lymph node high suspicious on imaging or confirm by biopsy. A minimun of 15 examined lymph nodes is recommended). All pts were received D2 gastrectomy;
The exfoliative cancer cells detection in peritoneal washes was positive;
Complete 8 cycles XELOX adjuvant chemotherapy and no recurrence / metastasis occurred. No more than 28 days from screening time to the end of chemotherapy; XELOX: Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d;
Pts never received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
Major organ function has to meet the following criteria:
ANC ≥ 1.5 × 109 / L HB ≥ 90g / L PLT ≥ 100 × 109 / L Bilirubin <1.5 times the upper limit of normal (ULN) ALT and AST <2.5 × ULN
An expected survival of ≥ 3 months;
Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.
Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Qun, MD | Contact | 0311-86543035 | zhaoqun516@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth Affiliated Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |