Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 2

Conditions: Malignant Pleural Effusion,; Malignant Ascites

Treatments: Other: Drug-packaging microparticles

Study type: Interventional

Funder types: Other

Identifiers

NCT01854866

Soundny Biotech

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of malignant ascites or malignant pleural effusion

Exclusion criteria

• Non-malignant ascites or pleural effusion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Drug-packaging Microparticles

Experimental group

Description:

Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week.

Treatment:

Other: Drug-packaging microparticles