Adjuvant immunotherapy after surgery for patients with peritoneal mesothelioma
- 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
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
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
Name Time Method 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
Name Time Method 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.
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