Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion
- Conditions
- Malignant Pleural Effusion,Malignant Ascites
- Interventions
- Other: Drug-packaging microparticles
- Registration Number
- NCT01854866
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief Summary
Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer. Currently, the management of malignant ascites and pleural effusion is a considerable clinical challenge. The investigator hypothesized that tumor cell-derived microparticles packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for Phase II clinical trials.
- Detailed Description
Ascites or pleural effusion were first removed from patients. The patients were then locally injected with microparticles packaging chemotherapeutic drugs 4 times a week. The therapeutic effects and side effects were recorded.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Clinical diagnosis of malignant ascites or malignant pleural effusion
- Non-malignant ascites or pleural effusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug-packaging Microparticles Drug-packaging microparticles Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week.
- Primary Outcome Measures
Name Time Method Volume of Ascites or Pleural Effusion 10 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hubei Provincial Traditional Chinese Medical Hospital
🇨🇳Wuhan, Hubei, China