NCT02657460

Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.

Detailed description

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.

Conditions

• Malignant Pleural Effusion

Interventions

Type	Name	Description
BIOLOGICAL	tumor derived microparticles	The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.
DRUG	cisplatin	cisplatin is a traditional drug for lung cancer

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-01-15
• Last updated: 2019-02-26

Locations

1 site across 1 country: China