2026-525223-24-00招募中2 期
A randomized phase II study comparing the safety and efficacy of mifamurtide and standard therapy containing sorafenib in pediatric and young adult patients with high-risk osteosarcoma
Instytut Matki I Dziecka2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月1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
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- EFS (Event-Free Survival) – the time from randomization to the first event, i.e., death, disease progression, or disease relapse, whichever occurs first. Assessment will be conducted from the date of randomization to the date of the event or to the date of the last available assessment.
研究概览
简要总结
Evaluation of clinical outcomes of treatment in the study patients, in particular event-free survival (EFS), and exploratory analysis of their relationship with molecular characteristics of the tumor
研究设计
- 分配方式
- Na
- 主要目的
- Faza follow-up Wizyta kończąca udział w badaniu (EoS)
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 5 years and ≤ 30 years at the time of study enrollment.
- •Recovery from adverse effects of prior surgery and/or radiotherapy.
- •Consent to use effective contraception throughout the study period and for at least 1 year after discontinuation of study treatment in patients at pubertal and sexual maturity.
- •Osteosarcoma confirmed by histopathological examination based on previously performed tests.
- •Providing written, informed consent to participate in the study (including treatment with mifamurtide and sorafenib) in accordance with current legal regulations.
- •Patient classified as high-risk.
- •Life expectancy of at least 12 weeks from the date of signing the informed consent.
- •Patient deemed fit to receive systemic treatment.
- •Patient deemed able to swallow tablets.
- •Disease in complete remission or stable disease according to WHO criteria prior to randomization.
- •Completed surgery (major surgery ≥ 2 weeks) and radiotherapy (≥ 4 weeks) prior to IMP administration.
排除标准
- •Failure to meet any of the inclusion criteria.
- •Arterial or venous thrombotic or embolic events, such as stroke (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the last 6 months before the first study drug administration.
- •Active hepatitis B or C infection or chronic hepatitis B or C infection requiring antiviral therapy.
- •Any bleeding or hemorrhagic event ≥ CTCAE v5 grade 3 within 4 weeks before the first study drug administration.
- •Diagnosis of other malignancies prior to study enrollment.
- •Planning to become pregnant, being pregnant, or breastfeeding.
- •Other acute or persistent disorders, behaviors, or abnormal laboratory test results that may increase the risks associated with participation in this clinical trial or with the study drug, or that may affect the interpretation of the study results, or that, in the opinion of the investigator, disqualify the patient from participating in the study.
- •Prior treatment with mifamurtide.
- •Hypersensitivity to the study drug or any of its components (including mifamurtide and sorafenib).
- •Concomitant treatment with other drugs that may interact with mifamurtide or sorafenib or other cytotoxic agents.
- •Persistent toxicity related to prior therapy precludes treatment with mifamurtide or sorafenib.
- •Significant cardiac conduction abnormalities, including known familial long QT syndrome or a screening corrected QT interval (QTc) >480 ms.
- •Symptoms of congestive heart failure or left ventricular ejection fraction <50%.
- •Requirement or likely need for corticosteroids at doses >10 mg prednisolone (or equivalent) daily or other immunosuppressive medications.
- •Uncontrolled blood pressure (blood pressure values not maintained within the recommended range (≥140/90 mmHg) despite treatment).
研究组 & 干预措施
MIFAMURTIDE
Test
干预措施: MIFAMURTIDE (Drug)
SORAFENIB
Comparator
干预措施: SORAFENIB (Drug)
结局指标
主要结局
EFS (Event-Free Survival) – the time from randomization to the first event, i.e., death, disease progression, or disease relapse, whichever occurs first. Assessment will be conducted from the date of randomization to the date of the event or to the date of the last available assessment.
EFS (Event-Free Survival) – the time from randomization to the first event, i.e., death, disease progression, or disease relapse, whichever occurs first. Assessment will be conducted from the date of randomization to the date of the event or to the date of the last available assessment.
次要结局
- OS (Overall Survival) – Overall survival will be measured from randomization to death from any cause; for patients alive at the end of follow-up, data will be censored at the date of last confirmed contact.
- PFS (Progression-Free Survival) – Progression-free survival will be measured from randomization to the date of disease progression or death, whichever occurs first.
- ORR (Overall Response Rate) – Response rate, defined as the percentage of patients with the best documented complete response (CR) or partial response (PR), assessed according to RECIST v1.1 at the time points specified in the imaging schedule.
- Evaluation of the safety of mifamurtide in patients with osteosarcoma. Safety will be assessed based on the number of serious adverse events (SAEs), the number of adverse events (AEs), a physical examination with analysis of recorded vital signs and laboratory abnormalities according to NCI CTCAE v5.0, from the start of treatment to the end of safety follow-up according to the study schedule.
研究者
Prof. dr hab. n. med. Anna Raciborska
Scientific
Instytut Matki I Dziecka
研究点 (2)
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