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UnknownNCT03230708

Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites

A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
18 (estimated)
Sponsor
Hui ting Xu,MD · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This study makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. All the participants will randomly receive the treatment of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination or convention drugs peritoneal perfusion and systemic therapy combination.

Detailed description

As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility, high immune compatibility, simple structure and easy access. In this study, microparticles released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill tumor cells in malignant ascites. These microparticles can easily reach the tumor site and bring the drug into tumor cells, which can overcome the two main problems in normal chemotherapy: damage to normal cells and drug resistance of tumor cells.

Conditions

Interventions

TypeNameDescription
OTHERErythrocytes derived MPs containing MTXGeneral conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX
DRUGconvention drugsaccording to usage method of drugs

Timeline

Start date
2017-05-01
Primary completion
2017-12-01
Completion
2018-02-01
First posted
2017-07-26
Last updated
2017-07-26

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03230708. Inclusion in this directory is not an endorsement.