Soft Tissue Sarcoma
Conditions
Brief summary
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.
Interventions
DRUGAnlotinib
Anlotinib p.o. qd
DRUGPlacebo
Placebo p.o. qd
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent * Histological documentation of Soft Tissue Sarcoma,including Synovial sarcoma、Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma，With measurable disease. * Within the past 6 months, using at least one failure of chemotherapy regimens (including anthracycline-based) in treating patients(except alveolar soft part sarcoma) * 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months * Main organs function is normal * The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
Exclusion criteria
* Prior treatment with Anlotinib * With pleural effusion or ascites, cause respiratory syndrome * Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients * Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping * Symptoms of brain metastases cannot be controlled and treated within less than 2 months * With severe and failed to controlled diseases * Occurred venous thromboembolic events within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS) | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | up to 24 months |
| Objective Response Rate (ORR) | up to 24 months |
| Disease Control Rate (DCR) | up to 24 months |
Countries
China
Outcome results
None listed