Actively Recruiting
NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
Led by University Hospital, Antwerp · Updated on 2025-08-13
37
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are: Can two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively? Does this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes? Participants will: Receive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed) Receive dual immunotherapy (nivolumab and ipilimumab) Undergo evaluation by a multidisciplinary team to determine if surgery is possible If operable, undergo extended pleurectomy/decortication surgery Be followed for one year to assess side effects, quality of life, and survival
CONDITIONS
Official Title
NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and follow study procedures
- Diagnosed with pleural epithelioid mesothelioma, clinical stage T2-3 N0-1 M0 according to TNM 9, initially considered inoperable
- Aged 18 years or older
- World Health Organization (WHO) performance status of 0 or 1
- Medically fit for chemotherapy, immunotherapy, and surgery
- Women of childbearing potential and men must use effective contraception to prevent pregnancy
You will not qualify if you...
- Patients with operable pleural mesothelioma (T1) or those unlikely to become operable after treatment (some T3, all T4, N2-3, M1)
- Presence of contralateral mediastinal lymph nodes (N2) or distant metastases
- Unfit for chemotherapy, immunotherapy, or thoracic surgery due to active autoimmune disease, prior splenectomy, active infections needing antibiotics, chronic infections (e.g., HIV, hepatitis B or C), or serious heart disease
- Allergic or sensitive to study drugs or their components (platinum salts, pemetrexed, ipilimumab, nivolumab)
- Having another active cancer except for certain skin or cervical cancers
- Previous treatment with chemotherapy, immunotherapy, surgery (except diagnostic thoracoscopy), or thoracic radiation therapy
- Significant mental health or social conditions that could affect study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
P
Prof. J. Hendriks, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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