Condition or disease | Intervention/treatment | Phase |
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Soft Tissue Sarcoma Adult High Grade Sarcoma | Drug: Anlotinib Hydrochloride Drug: Placebo Oral Tablet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Anlotinib Hydrochloride (AL3818) in Postoperative Adjuvant Therapy for High-grade Soft Tissue Sarcoma -- A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trail |
Estimated Study Start Date : | May 13, 2019 |
Estimated Primary Completion Date : | May 13, 2022 |
Estimated Study Completion Date : | August 13, 2022 |
Arm | Intervention/treatment |
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Experimental: Anlotinib Gruop |
Drug: Anlotinib Hydrochloride
Before breakfast, take an Anlotinib hydrochloride placebo once a day, 12 mg (1 pill) at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.
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Placebo Comparator: Placebo Group |
Drug: Placebo Oral Tablet
Before breakfast, take an placebo once a day, 1 pill at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1.High-grade soft tissue sarcoma patients without standard adjuvant chemotherapy after surgery. Mainly includes: liposarcoma(except for Myxoid/round cell liposarcoma), leiomyosarcoma, malignant peripheral nerve sheath tumor, fibrosarcoma, clear cell sarcoma, alveolar soft part sarcoma, angiosarcoma, epithelioid sarcoma, malignant solitary fibrous tumor and so on. Except for rhabdomyosarcoma, gastrointestinal stromal tumors, dermatofibrosarcoma protuberans, Ewing sarcoma/primary neuroectodermal tumors, inflammatory myofibroblastoma, malignant mesothelioma.
2.The postoperative microscopic margin was negative and the pathological diagnosis was high-grade soft tissue sarcoma. The diagnosis was completed by pathologists, and the pathological specimens were confirmed by the research center.
3.The age is ≥18 years old, the ECOG score is ≤2, and the estimated survival time is more than 3 months.
4.Examinations meet the following criteria:
6.Patients should participate in the study involuntarily, sign the informed consent, and have good compliant and agree to be followed up.
Exclusion Criteria:
1. Patients who have received targeted therapy of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib and apatinib, etc.
2. Patients who have malignant tumors previously or concomitantly, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Those who participated in other drug clinical trials within 4 weeks; 4. Those who received chemotherapy within 4 weeks. 5. Those who received anticancer therapy previously and have toxic reactions of NCI-CTC AE grade > grade 1 now; 6. Patients who have multiple factors affecting oral medication (such as inability to swallow, Post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 7. Patients who have brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of brain or pia mater disease.
8. Patients have any serious or uncontrolled disease, such as:
11. Arterial or venous thrombosis occurred before the first dose, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
12. Those who have a history of psychotropic drug abuse and are unable to get rid of or have mental disorders.
13. Those who have a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disorders, or organ transplantation.
14. According to the investigator's assessment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.
Contact: Wangjun Yan, M.D. | +86 18121299399 | yanwj@fudan.edu.cn | |
Contact: Chunmeng Wang, M.D. | +86 18017317143 | cmwang1975@163.com |
China, Guangdong | |
Cancer Hospital of Sun Yat-sen | |
Guangzhou, Guangdong, China, 510060 | |
Contact: Jing Wang, M.D. | |
Sub-Investigator: Jing Wang, M.D. | |
China, Yunnan | |
Yunnan Cancer Hospital | |
Kunming, Yunnan, China, 650118 | |
China, Zhejiang | |
Zhengjiang Cancer Hospital | |
Hangzhou, Zhejiang, China, 310022 | |
Contact: Tao Li, M.D. | |
Sub-Investigator: Tao Li, M.D. | |
China | |
Fudan University Shanghai Cancer Center | |
Shanghai, China, 200032 | |
Contact: Wangjun Yan, M.D. 18121299399 yanwj@fudan.edu.cn | |
Contact: Chunmeng Wang, M.D. 18017317143 cmwang1975@163.com | |
Principal Investigator: Wangjun Yan, M.D. | |
Principal Investigator: Chunmeng Wang, M.D. | |
The Six People's Hospital Affiliated to Shanghai Jiao Tong University | |
Shanghai, China, 200233 | |
Contact: Yang Dong, M.D. | |
Sub-Investigator: Yang Dong, M.D. |
Principal Investigator: | Wangjun Yan | Fudan University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 10, 2019 | ||||||||
First Posted Date ICMJE | May 15, 2019 | ||||||||
Last Update Posted Date | May 15, 2019 | ||||||||
Estimated Study Start Date ICMJE | May 13, 2019 | ||||||||
Estimated Primary Completion Date | May 13, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Efficacy and Safety of Anlotinib in Adjuvant Therapy for High-grade Soft Tissue Sarcoma | ||||||||
Official Title ICMJE | Efficacy and Safety of Anlotinib Hydrochloride (AL3818) in Postoperative Adjuvant Therapy for High-grade Soft Tissue Sarcoma -- A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trail | ||||||||
Brief Summary | To evaluate the efficacy and safety of Anlotinib Hydrochloride Capsule combined with Best Supportive Therapy in the adjuvant treatment of patients with high-grade soft tissue sarcoma after operation, as compared with placebo combined with Best Supportive Therapy. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
88 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 13, 2022 | ||||||||
Estimated Primary Completion Date | May 13, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03951571 | ||||||||
Other Study ID Numbers ICMJE | IRB1902197-8 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wangjun Yan, Fudan University | ||||||||
Study Sponsor ICMJE | Fudan University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Fudan University | ||||||||
Verification Date | May 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |