Observation of the Efficacy and Safety of Oncolytic Adenovirus Injection Combined With Programmed Death Receptor Inhibitors in Treatment of Advanced Malignant Pleural Mesothelioma : a Single Center, Prospective, Case Registration Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- ORR(Objective Response Rate)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Oncolytic Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.
详细描述
By monitoring the clinical symptoms of patients with advanced immune resistant pleural mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1) inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the drug, and finally evaluate the quality of life of patients using oncolytic adenovirus injection(H101) combined with PD-1 inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18-75 years old (including boundary values), regardless of gender.
- •Confirmed as late stage MPM patients who have failed immunotherapy.
- •The patient or their legal representative can understand and sign the informed consent form.
- •At least one lesion that can safely undergo intratumoral injection or intrapleural injection of oncolytic adenovirus as the target lesion, with a diameter of spiral CT ≥ 1cm or ordinary CT ≥ 2cm, and can be measured through imaging methods.
- •ECOG score 0-2.
排除标准
- •Physicians participating in the study believe that patients may not be able to provide continuous follow-up information.
- •Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases).
- •Contraindications to relevant drugs (such as oncolytic adenoviruses, PD-1 inhibitors, etc.)
研究组 & 干预措施
Oncolytic adenovirus(H101) combined with PD-1 inhibitors
This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.
干预措施: Oncolytic Adenovirus H101 (Drug)
Oncolytic adenovirus(H101) combined with PD-1 inhibitors
This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.
干预措施: Programmed death receptor-1 inhibitor (Drug)
结局指标
主要结局
ORR(Objective Response Rate)
时间窗: 36 months
The proportion of CR(complete response) and PR(partial response) in all patients.
DCR(Disease Control Rate)
时间窗: 36 months
The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.
次要结局
- PFS(Progression Free Survival)(36 months)
- AEs(Adverse Events)(36 months)
- OS(Overall Survival)(36 months)