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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 first-line chemotherapy in Postoperative Recurrence / Metastasis Progressive Gastric Cancer.
Eligible patients will receive apatinib treatment(500mg qd p.o. q28d) until until disease progression or intolerable toxicity or patients withdrawal of consent after 4 cycles of DC first-line chemotherapy or only DC first-line chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib Maintenance Therapy After First-line Chemotherapy | Experimental | Apatinib Mesylate Tablets 500 mg qd p.o. after DC First-line Chemotherapy (Docetaxel 60-85mg/m2 i.v. d1, Cisplatin 60-75mg/m2 i.v. d1, q21d) |
|
| No Intervention After First-line Chemotherapy | No Intervention | No Intervention after DC First-line Chemotherapy (Docetaxel 60-85mg/m2 i.v. d1, Cisplatin 60-75mg/m2 i.v. d1, q21d) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib Mesylate Tablets 500 mg qd p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | An expected average of 12 weeks |
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Inclusion Criteria:
Age: 18 to75 years old;
Histologically proven progressive gastric cancer. All pts were received D2 gastrectomy and recurrence / metastasis occured;
Complete 4 cycles DC first-line chemotherapy and no and no disease progression occurred. DC: Docetaxel 60-85mg/m2 iv d1, Cisplatin 60-75mg/m2 iv d1, q21d;
ECOG PS of 0-1;
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; liver metastases, if any, the ALT and AST<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 |