NCT06585527招募中1 期
A Clinical Study of the Safety and Efficacy of Third-generation Oncolytic TS-2021 in the Treatment of Recurrent Malignant Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events.
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant glioma will :
- Be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.
- Be followed for 1 year after the injection to complete imaging studies, neurological function tests, and report adverse events.
Using the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient signed the informed consent voluntarily.
- •Age ≥18 years and ≤65 years, male or female.
- •After the initial surgery, the imaging showed that the tumor was completely removed, followed by conventional radiotherapy or (and) chemotherapy, and no recurrence was observed within two months after the end of radiotherapy. The patient had a recurrence of supratentorial high-grade glioma. The pathological diagnosis was glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendro-astrocytoma, or subtentorial astrocytoma recurrence.
- •After conventional surgery, radiotherapy (or) chemotherapy was performed, and there was no recurrence at the primary site of the tumor, but there was tumor recurrence at the distant site.
- •With PET/MRS, tumor recurrence was considered, and the enhanced lesion diameter was greater than 1cm, but less than 3cm.
- •KPS score ≥70 before treatment.
- •Normal bone marrow reserve function and normal liver and kidney function: Neutrophil absolute value ≥ 1,500/mm3, hemoglobin ≥10 g/dL, platelet count ≥100,000/mm3, total bilirubin level ≤1.5×ULN, glutamic pyruvic transaminase/glutamic oxalacetic transaminase ≤ 2.5× ULN, serum creatinine ≤1.5×ULN, The heart function was normal and the follow-up compliance was good.
- •Women of childbearing age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment.
排除标准
- •Pregnant or lactating patients.
- •Patients with encephalitis disease, multiple sclerosis, or other CNS (Central Nervous System) infection.
- •Patients with a history of organ transplantation or waiting for organ transplantation.
- •Patients with uncontrolled infectious diseases or other serious diseases, such as HIV positive.
- •Patients with any unstable systemic illness (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 12 months before enrollment, severe arrhythmia requiring medical treatment, liver or kidney failure, etc.)
- •Patients with systemic autoimmune diseases or immunodeficiency diseases.
- •Patients with severe allergic constitution.
- •Patients with chronic diseases requiring long-term treatment with immune agents or glucocorticoids.
- •Patients with mental disorders.
研究组 & 干预措施
TS-2021
Experimental
30 eligible participants with recurrent malignant glioma will be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.
干预措施: TS-2021 (Biological)
结局指标
主要结局
Incidence and severity of adverse events.
时间窗: Up to 8 weeks
All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to TS-2021.
Overall survival
时间窗: Up to 12 months
The overall survival for each patient receiving TS-2021 will be calculated.
次要结局
- Objective response rate (ORR) determined by MRI scan review.(Up to 12 months)
- Progression Free Survival.(Up to 12 months)
研究者
研究点 (1)
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