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Recruiting
NCT05655663
Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer
Conditions: Head and Neck Cancer, Lung Cancer
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: Centre Henri Becquerel
Location: France
Summary
Since the introduction of immune checkpoint ihibitors (ICIs) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs.
Currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining ICIs with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or RNA injected to trigger or increase a specific immune response against the tumor.
Other approaches exist, such as oncology-specific "basket" studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations.
To date, ICIs are part of standard management in the US for patients with several diseases: advanced melanoma, NSCLC, Merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory Hodgkin's lymphoma, hepatocellular carcinoma, gastric cancer.
In addition, trials are underway to investigate the benefit of ICIs in other locations.Thus, taking into account the growing importance of ICIs in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary.
Eligibility Criteria
Inclusion Criteria:Signed informed consent.Patient over 18 years of agePatient with lung or head and neck cancer who should be treated with ICI as a single agent according to the market indications, decision taken during a multidisciplinary consultation meetingWHO 0 or 1Patient affiliated to or benefiting from a social protection scheme.Exclusion Criteria:Indication for combined anti-PD-1 and chemotherapy (for patients with lung cancer)History of radiotherapy treatmentHistory of chemotherapy or targeted therapy within the last 3 weeksBilateral vascular carotid murmurAbsence of sinus rhythmPresence of a pacemaker with permanent electrical stimulationAbsence of peripheral carotid and/or femoral pulses on both sidesContraindication to the prescription of an ICIPatient deprived of liberty by an administrative or judicial decision or patient placed under court protection, guardianship or curatorshipPregnant or breastfeeding woman
Source: ClinicalTrials.gov (NCT05655663). StuddyBuddy aggregates publicly available trial information.