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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;

2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;

3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;

4. 18-70 years old;

5. normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;

6. agreed to participate in the study and sign an informed consent;

7. without other severe comorbidities.

Exclusion Criteria:

1. lactating or pregnant patients;

2. allergy to multiple drugs;

3. with other severe comorbidities or psychological diseases;

4. severe infection;

5. participation in other clinical trials within the recent three months.