NCT03393858

Combination of Immunotherapy and Hyperthermia in Advanced Malignant Mesothelioma

A Prospective Study of Combination of Anti-PD-1 Plus Autologous DC-CIK Cell Immunotherapy and Hyperthermia for Patients With Advanced Malignant Mesothelioma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the clinical efficacy and toxicity of anti-PD-1 monoclonal antibody plus autologous dendritic cells-cytokine induced killer cell (DC-CIK) immunotherapy combined with hyperthermia in advanced malignant mesothelioma patients.Furthermore,to characterize response to therapy,the investigators intent to explore the predictive biomarker for this regimen.

Conditions

• Cancer
• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	Anti-PD-1 antibody	Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
BIOLOGICAL	DC-CIK Immunotherapy	Mononuclear cells were collected from 50ml peripheral blood , and cultured DC-CIK cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.
DEVICE	Thermotron RF-8EX	Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week since the 1st week of pembrolizumab for a total of 10 times.

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2018-01-09
• Last updated: 2024-02-07

Locations

1 site across 1 country: China