Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pleural effusions volume
研究概览
简要总结
The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.
详细描述
Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
- •The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
- •stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
- •18-70 years old;
- •normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;
- •agreed to participate in the study and sign an informed consent;
- •without other severe comorbidities.
排除标准
- •lactating or pregnant patients;
- •allergy to multiple drugs;
- •with other severe comorbidities or psychological diseases;
- •severe infection;
- •participation in other clinical trials within the recent three months.
研究组 & 干预措施
MTX-ATMPs
methotrexate-autologous tumor derived microparticles
干预措施: tumor derived microparticles (Biological)
cisplatin
Cisplatin is a traditional treatment for lung cancer
干预措施: cisplatin (Drug)
结局指标
主要结局
Pleural effusions volume
时间窗: four weeks
次要结局
- the cytology test of pleural effusions(four weeks)
- neuron specific annuals level in microgramme/L in serum(four weeks)
- carcino embryonie antigen level in microgramme/L in pleural effusions(four weeks)
- Karnofsky index(four weeks)
- survival time(six month)
- squamous cell carcinoma antigen level in ng/mL in serum(four weeks)
- Rivalta Test of pleural effusions(four weeks)
- total protein level of pleural effusions(four weeks)
- adenosine deaminase level of pleural effusions(four weeks)
- total karyocytes count of pleural effusions(four weeks)
- lactic dehydrogenase level of pleural effusions(four weeks)
- carcino embryonie antigen level in microgramme/L in serum(four weeks)
- CYFRA21-1 level in ng/mL in serum(four weeks)
研究者
Yang Jin
Professor
Wuhan Union Hospital, China