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

Phase II Study of Tumor Cell-derived Microparticles Used as Vectors of Chemotherapeutic Drugs to Treat Malignant Ascites and Pleural Effusion

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01854866

Enrollment

Registered

2013-05-16

Start date

2013-05-31

Completion date

2014-03-31

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Ascites, Malignant Pleural Effusion,

Keywords

Pleural Effusion, ascites, Malignant

Brief summary

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.

Detailed 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.

Interventions

OTHERDrug-packaging microparticles

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of malignant ascites or malignant pleural effusion

Exclusion criteria

* Non-malignant ascites or pleural effusion

Design outcomes

Primary

Measure	Time frame
Volume of Ascites or Pleural Effusion	10 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026