NCT05747339尚未招募不适用
The Efficacy and Safety of Tumor Treatment Vaccine in Patients With Advanced Solid Tumors
Wuxi People's Hospital0 个研究点目标入组 50 人开始时间: 2023年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Relief degree of tumors
研究概览
简要总结
This is a study of the clinical efficacy and mechanism study of tumor treatment vaccine (TTV, also known as Neo-BCV) in patients with recurrent and refractory advanced solid tumors.
详细描述
The study aims to explore the safety and effectiveness of Neo-BCV in the treatment of advanced solid tumors.The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-75 years;
- •ASubjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
- •Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
- •ECOG score of 0-2, lifespan > 12 weeks;
- •Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
- •Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
排除标准
- •The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
- •White blood cell count ≥ 50×10^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
- •Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
- •HIV, HBV and HCV positive;
- •Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
- •Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
- •Patients are on anticoagulation or have severe coagulopathy (APTT>70);
- •Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
- •Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
- •Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
- •Subjects in other conditions that are considered unsuitable for this study by the investigator.
结局指标
主要结局
Relief degree of tumors
时间窗: The last injection
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
次要结局
- Overall survival（OS）(3 years)
- Progress free survival（PFS）(1 year)
研究者
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