Clinical trial NCT02449343: Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)
Official title: A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Soft Tissue Sarcoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.


Eligibility criteria: 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

Primary outcomes:
measure: Progress free survival (PFS)
timeFrame: up to 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 24 months
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
measure: Disease Control Rate (DCR)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The 1st Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Meidical University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Cancer Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen university
state: Guangdong
city: Nanning
country: China
facility: Guangxi medical university affiliated tumor hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The Third Hospital of hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin medical university affiliated tumor hospital
state: Heilongjiang
city: Luoyan
country: China
facility: Henan Province Tumor Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Province Tumor Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Province Tumor Hospital
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital , Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
References: