Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion
NCT04131231 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248
Last updated 2019-10-18
Summary
This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.
Conditions
- Lung Cancer
- Breast Cancer
- Malignant Pleural Effusion
Interventions
- DRUG
-
microparticles packaging methotrexate (MPs-MTX)
50ml, intrapleural infusion, day5,6,7,8
- DRUG
-
recombinant human interleukin-2(rhIL-2)
50ml, intrapleural infusion, day5,8,11
Sponsors & Collaborators
-
Peking Union Medical College
lead OTHER
Principal Investigators
-
Fei Ma, MD · Cancer Hospital Chinese Academy of Medical Science
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-15
- Primary Completion
- 2021-01-15
- Completion
- 2021-06-15
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