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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.
cisplatin is a traditional drug for lung cancer
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGPleural effusions volume
Time frame: four weeks
Rivalta Test of pleural effusions
Time frame: four weeks
total protein level of pleural effusions
Time frame: four weeks
total karyocytes count of pleural effusions
Time frame: four weeks
lactic dehydrogenase level of pleural effusions
Time frame: four weeks
adenosine deaminase level of pleural effusions
Time frame: four weeks
the cytology test of pleural effusions
Time frame: four weeks
Karnofsky index
Time frame: four weeks
survival time
Time frame: six month
carcino embryonie antigen level in microgramme/L in serum
Time frame: four weeks
CYFRA21-1 level in ng/mL in serum
Time frame: four weeks
neuron specific annuals level in microgramme/L in serum
Time frame: four weeks
squamous cell carcinoma antigen level in ng/mL in serum
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Time frame: four weeks
carcino embryonie antigen level in microgramme/L in pleural effusions
Time frame: four weeks