NCT04131231

Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion

Safety and Effectiveness of Microparticles Packaging Chemotherapeutic Drugs(MPCD) Therapy on the Treatment of Malignant Pleural Effusion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Peking Union Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.

Detailed description

After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Randomization is stratified by tumor type and previous treatment. Patients in the MPCD group are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. Patients in the control group are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), the efficacy is assessed according to the WHO (1997) Response Evaluation Criteria In MPE and the evaluation methods mainly include physical examination, ultrasound and computed tomography (CT). The patients will be monitored by telephone every three months.

Conditions

• Lung Cancer
• Breast Cancer
• Malignant Pleural Effusion

Interventions

Type	Name	Description
DRUG	microparticles packaging methotrexate (MPs-MTX)	50ml, intrapleural infusion, day5,6,7,8
DRUG	recombinant human interleukin-2(rhIL-2)	50ml, intrapleural infusion, day5,8,11

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-01-15
• Completion: 2021-06-15
• First posted: 2019-10-18
• Last updated: 2019-10-18