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


Phase 2
18 Years
70 Years
Open (Enrolling by invite only)
Both
Malignant Pleural Effusion,, Malignant Ascites

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Trial Information

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


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.


Inclusion Criteria:



- Clinical diagnosis of malignant ascites or malignant pleural effusion

Exclusion Criteria:

- Non-malignant ascites or pleural effusion

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Volume of Ascites or Pleural Effusion

Outcome Time Frame:

10 months

Safety Issue:

Yes

Principal Investigator

Bo Huang, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huazhong University of Science and Technology

Authority:

United States: Food and Drug Administration

Study ID:

Soundny Biotech

NCT ID:

NCT01854866

Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Malignant Pleural Effusion,
  • Malignant Ascites
  • Pleural Effusion
  • ascites
  • Malignant
  • Ascites
  • Pleural Effusion
  • Pleural Effusion, Malignant

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