Soft Tissue Sarcoma
Conditions
Brief summary
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.
Interventions
DRUGapatinib
apatinib 500mg po. qd.
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 aptinib；at least 1 month since prior inhibitor of mTOR or EGFR pathway. * Not pregnant or nursing；Fertile patients must use effective contraception. * Hematopoietic * HB≥90g/L * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 80,000/mm\^3
Exclusion criteria
* Uncontrollable hypertension; * Has influence of oral drugs; * Patients with high risk of gastrointestinal blooding; * INR\>1.5×ULN，APTT\>1.5×ULN; * Allergic to any ingredient of this product; * Less than 1 month since last major surgery; * Brain metastases; * With the second cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 months PFS rate | From baseline to 6 months | Analyse PFS rate at 6 months |
Outcome results
None listed