Efficacy and Safety of Anlotinib in Adjuvant Therapy for High-grade Soft Tissue Sarcoma
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
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Shanghai、中国、200032
- Fudan University Shanghai Cancer Center
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Shanghai、中国、200233
- The Six People's Hospital Affiliated to Shanghai Jiao Tong University
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Cancer Hospital of Sun Yat-sen
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Yunnan
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Kunming、Yunnan、中国、650118
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou、Zhejiang、中国、310022
- Zhengjiang Cancer Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
- Blood routine examination: HB ≥ 100g/L(no blood transfusion within 14 days); ANC ≥ 1.5×10^9 /L; PLT ≥ 80×10^9 /L
- Other examinations: Cr ≤ upper limit of normal value (ULN); BIL ≤ ULN; ALTAST ≤ 1.5 × ULN (for patients with liver metastasis ≤ 5 × ULN); fasting triglyceride ≤3.0mmol/L; fasting cholesterol ≤7.75mmol/L;
- Doppler ultrasound assessment: LVEF ≥ 50%. 5. Females should agree to use contraceptives (such as intrauterine devices (IUD), birth control pills or condoms) during the study period and 6 months after the end of study and the serum or urine pregnancy test was negative within 7 days prior to study enrollment and must be non-lactating; Males should agree to use contraception during the study period and within six months after the end of the study period.
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:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmia; patients with unsatisfactory blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
- Active or uncontrolled severe infections;
- Liver diseases such as cirrhosis, decompensated liver disease and chronic active hepatitis;
- Poor control of diabetes mellitus (FBG > 10mmol/L);
- Urinary routine examination showed that urinary protein (++) and confirmed by the 24-hour urinary protein quantification(>1.0 g); 9. Long-term unhealed wound or fracture 10. Patients with bleeding tendency (e.g. active gastrointestinal ulcer) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues.
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:安慰剂组
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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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实验性的:Anlotinib Gruop
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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深度FS
大体时间:2年
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无病生存
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2年
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1-year and 2-year DFR
大体时间:2 years
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1-year and 2-year disease-free survival rates
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
操作系统
大体时间:2年
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总生存期
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2年
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LRFS
大体时间:2 years
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Local Recurrence Free Survival
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2 years
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DMFS
大体时间:2 years
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Distant Metastasis Free Survival
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2 years
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合作者和调查者
调查人员
- 首席研究员:Wangjun Yan、Fudan University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB1902197-8
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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