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Apatinib is a kind of innovative medicines approved by China Food and Drug Administration(CFDA), which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd. Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib group | Experimental | apatinib 500mg po qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | apatinib 500mg po. qd. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 months PFS rate | Analyse PFS rate at 6 months | From baseline to 6 months |
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Inclusion Criteria:
Signed informed consent.
Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma.
Must have evidence of unresectable residual disease.
In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment.
ECOG ps≤2.
Life expectancy: more than 3 months.
Prior aptinib less than 2 weeks and at least 1 month since prior aptinibï¼›at least 1 month since prior inhibitor of mTOR or EGFR pathway.
Not pregnant or nursingï¼›Fertile patients must use effective contraception.
Hematopoietic
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36267741 | Derived | Yu W, Zhang H, Chen J, Zhang X, Chen Y, Qu G, Huang G, Zhou Y, Ye T, Fan Z, Yao Y. Efficacy and safety of apatinib in patients with untreated or chemotherapy-refractory soft tissue sarcoma: a multicenter, phase 2 trial. Ann Transl Med. 2022 Sep;10(18):981. doi: 10.21037/atm-22-4229. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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