Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)
- Registration Number
- NCT02449343
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 233
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Anlotinib Anlotinib Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- Primary Outcome Measures
Name Time Method Progress free survival (PFS) up to 24 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) up to 24 months Objective Response Rate (ORR) up to 24 months Disease Control Rate (DCR) up to 24 months
Trial Locations
- Locations (25)
Gansu Cancer Hospital
🇨🇳Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Guangxi medical university affiliated tumor hospital
🇨🇳Nanning, Guangxi, China
The Third Hospital of hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Harbin medical university affiliated tumor hospital
🇨🇳Harbin, Heilongjiang, China
Tianjin Hospital
🇨🇳Tianjin, Tianjin, China
The 1st Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Meidical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Sun Yat-sen university
🇨🇳Guangzhou, Guangdong, China
Henan Province Tumor Hospital
🇨🇳Luoyan, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Hunan Province Tumor Hospital
🇨🇳Changsha, Hunan, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Fudan University Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Liaoning Province Tumor Hospital
🇨🇳Shenyang, Liaoning, China
West China Hospital , Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai 6th People's Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xian, Shanxi, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China