Last reviewed · How we verify

NCT06637345: MESORTIBO

Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)

Recruiting now Last updated 15 October 2024
What this trial tests

trial in Pleural Mesothelioma Malignant in 52 participants. Currently enrolling.

Timeline
15 March 2024
Primary endpoint
15 March 2027
15 March 2027

Quick facts

Lead sponsorCentro di Riferimento Oncologico - Aviano
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment52
Start date15 March 2024
Primary completion15 March 2027
Estimated completion15 March 2027
Sites1 location across Italy

Conditions studied

Sponsor

Centro di Riferimento Oncologico - Aviano

Who can join

18 and older, any sex, with Pleural Mesothelioma Malignant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage. In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes. Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM. This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Radical hemithorax radiotherapy induces an increase in circulating PD-1<sup>+</sup> T lymphocytes and in the soluble levels of PD-L1 in malignant pleural mesothelioma patients: a possible synergy with PD-1/PD-L1 targeting treatment?
    Revelant A, Gessoni F, Montico M, Dhibi R, et al · · 2025 · cited 2× · PMID 40236706 · DOI 10.3389/fimmu.2025.1534766

Verify or expand the search:

Other Centro di Riferimento Oncologico - Aviano trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06637345.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing