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The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Start Date
January 1, 2016
Primary Completion Date
December 1, 2019
Completion Date
December 1, 2019
Last Updated
February 26, 2019
90
ESTIMATED participants
tumor derived microparticles
BIOLOGICAL
cisplatin
DRUG
Lead Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NCT06016179
NCT06682936
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06421610