NCT05106777进行中（未招募）2 期
A Multi-center, Open Label Study of Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2021年12月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Progression-free rate at 12weeks
研究概览
简要总结
The purpose is to evaluate the effectiveness and safety of Surufatinib in patients with osteosarcoma and soft tissue sarcoma after Standard chemotherapy therapy.
详细描述
The study population is patients with advanced osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy treatment. Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle. Investigators will evaluate the clinical tumor response to Surufatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Surufatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Surufatinib with the agreement of the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the study and voluntarily sign the informed consent form;
- •Male or female, age14-70 years，the body surface area of patients under 18 years old is ≥1.5m2;
- •Histologically or cytologically confirmed advanced osteosarcoma and soft tissue sarcoma (unresectable or metastatic)；
- •The patient had previously failed standard chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2).
- •Life expectancy > 12 weeks.
- •Have measurable disease based on RECIST 1.1.
排除标准
- •Prior treatment with Surufatinib;
- •Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
- •Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
- •With pleural effusion or ascites, cause respiratory syndrome. (> CTC AE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily life])
- •had central nervous system metastasis;
- •With severe and failed to controlled diseases. (including:1)Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose > 10mmol / L).4)Active or uncontrolled serious infection (≥ Common Terminology Criteria for Adverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;7)Patients with seizures and need treatment.)
- •Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping.
- •Participated in other anti-tumor clinical trials within 4 weeks.
- •had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
- •were pregnant or breastfeeding.
研究组 & 干预措施
Surufatinib
Experimental
Drug: Surufatinib Surufatinib will be given orally.
干预措施: Surufatinib (Drug)
结局指标
主要结局
Progression-free rate at 12weeks
时间窗: at 12weeks
次要结局
- Objective response rate (ORR)(up to 12 months)
- Overall survival (OS)(up to 24 months)
- Progression-free survival (PFS)(up to 12 months)
- Disease control rate (DCR)(up to 12 months)
研究者
Xing Zhang
Professor
Sun Yat-sen University
研究点 (1)
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