MedPath

Adjuvant immunotherapy after surgery for patients with peritoneal mesothelioma

Recruiting
Conditions
Peritoneal mesothelioma
Registration Number
NL-OMON28091
Lead Sponsor
Erasmus Medical Center, Rotterdam
Brief Summary

de Boer NL, van Kooten JP, Burger JWA, Verhoef C, Aerts J, Madsen EVE. Adjuvant dendritic cell based immunotherapy (DCBI) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal mesothelioma, a phase II single centre open-label clinical trial: rationale and design of the MESOPEC trial. BMJ Open. 2019;9(5):e026779. van Kooten JP, de Boer NL, Burger JWA, Verhoef C, Aerts J, Madsen EVE. Adjuvante Dendritische Cel Immunotherapie na Cytoreductieve Chirurgie en Hypertherme Intraperitoneale Chemotherapie voor patiënten met Maligne Peritoneaal Mesothelioom. De MESOPEC studie. Nederlands Tijdschrift voor Oncologie. Jaargang 16, Nummer 2, Maart 2019.

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria, before undergoing CRS-HIPEC:

•Patients with a histologically or cytologically confirmed diagnosis of malignant peritoneal mesothelioma

Exclusion Criteria

A potential participant who meets any of the following criteria will be excluded from participation in the study:

•Extra-abdominal disease/ metastatic disease

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The main goal of this project is to determine the feasibility of administering DCBI after CRS-HIPEC in patients with malignant peritoneal mesothelioma.
Secondary Outcome Measures
NameTimeMethod
Secondary endpoint of this study is to assess safety in patients with peritoneal mesothelioma who are treated with DCBI, which has already been proven in patients with pleural mesothelioma. Another secondary endpoint of this study is the determination of an immunological response against the tumor as result of the adjuvant therapy.
© Copyright 2025. All Rights Reserved by MedPath