NCT06514313招募中2 期
Phase II Randomized Controlled Clinical Trial of Mitoxantrone Hydrochloride Liposome Combined With Irinotecan and Vincristine (VIM) With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
Yizhuo Zhang1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年7月3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
- 110
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.
详细描述
Children with relapsed/refractory soft tissue sarcoma who meet the inclusion criteria are randomly divided into VIM group and VIT group (irinotecan, vincristine, temozolomide) at 1:1. The efficacy and safety of the two groups are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 years ≤age≤21 years, no gender limitation.
- •The Karnofsky (≥16 years old) or Lansky (< 16 years old) physical status score is at least
- •The expected survival time is not less than 12 weeks.
- •Heart function: a) Cardiac COLOR ultrasound detection LVEF≥ 50%; b) ECG suggests no myocardial ischemia; c) No history of arrhythmia requiring drug intervention before enrollment.
- •Pathological results for patients of soft tissue sarcoma.
- •Patients with rhabdomyosarcoma are limited to first -, second -, and third-line treatment, and patients with other pathological subtypes are limited to progression, recurrence, or refractory after first-line treatment, with refractory defined as failure to achieve complete or partial response to the most recent treatment.
- •Measurable lesions (according to RECIST 1.1 standards, measurable lesions have not received radiotherapy, freezing and other local treatments).
- •The patient must fully recover from the acute toxic effects of all previous anticancer chemotherapy.
- •Good blood and organ function.
- •During study participation, patients are able to adhere to outpatient treatment, laboratory monitoring, and necessary clinical visits.
- •The parent/guardian of the child or adolescent subject is capable of understanding, agreeing to, and signing the study Informed consent (ICF) and the applicable child consent form prior to initiating any program-related procedures; Subject is capable of expressing consent with parental/guardian consent (if applicable).
排除标准
- •Once received mitoxantrone or mitoxantrone liposomes.
- •Patients who had received previous VIT (irinotecan + temozolomide + vincristine) chemotherapy.
- •Previous treatment with adriamycin or other anthracyclines with a total cumulative dose of adriamycin > 360 mg/m^2; Or patients with cardiac disease caused by previous anthracyclines.
- •Receiving or not being able to discontinue P450 enzyme-induced anticonvulsant drugs (e.g., phenytoin, carbamazepine, etc.) within 4 weeks or 5 half-life periods prior to enrollment.
- •Previous or concurrent clinical significance of active cardiovascular diseases.
- •Severe chronic skin diseases in the past.
- •Previous allergic asthma or severe allergic disease.
- •Uncontrolled hypertension and diabetes.
- •Have a history of other tumors, except cured cervical cancer or basal cell carcinoma of the skin.
- •Active hepatitis B or hepatitis C infection.
- •HIV or syphilis infected patients.
- •Patients who have previously received organ transplants.
- •Uncontrolled active systemic bacterial, viral, or fungal infection.
- •Contraindications to high-dose hormone use, such as uncontrolled hyperglycemia, gastric ulcers, or psychiatric disorders.
- •Severe neurological or psychiatric history, including epilepsy or autism.
- •Pregnant, lactating women and patients of childbearing age who are unwilling to use contraception.
- •Other circumstances deemed inappropriate by the investigator to participate in the study.
研究组 & 干预措施
VIM
Experimental
Mitoxantrone Hydrochloride Liposome combined with Irinotecan and Vincristine.
干预措施: Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine (Drug)
VIT
Active Comparator
Temozolomide combined with Irinotecan and Vincristine.
干预措施: Temozolomide+Irinotecan+Vincristine (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 cycles of chemotherapy (each cycle is 21 days)
Objective response rate (ORR) after 2 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR)
次要结局
- Objective response rate (ORR)(Up to 4 cycles of chemotherapy (each cycle is 21 days))
- Disease control rate (DCR)(Up to 4 cycles of chemotherapy (each cycle is 21 days))
- Progression-free survival (PFS)(From date of radomization unit the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 moths.)
- Overall survival (OS)(From date of radomization unit the date of first documented date of death from any cause, assessed up to 24 moths)
研究者
Yizhuo Zhang
Director
Sun Yat-sen University
研究点 (1)
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