Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer

Not Applicable

Recruiting

• Conditions: Lung Cancer; Head and Neck Cancer
• Interventions: Other: Vascular investigation

• Registration Number: NCT05655663
• Lead Sponsor: Centre Henri Becquerel

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-09
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19
• Study Start: 2022-12-20
• Primary Completion: 2025-02-10
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Signed informed consent.
• Patient over 18 years of age
• Patient 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 meeting
• WHO 0 or 1
• Patient 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 treatment
• History of chemotherapy or targeted therapy within the last 3 weeks
• Bilateral vascular carotid murmur
• Absence of sinus rhythm
• Presence of a pacemaker with permanent electrical stimulation
• Absence of peripheral carotid and/or femoral pulses on both sides
• Contraindication to the prescription of an ICI
• Patient deprived of liberty by an administrative or judicial decision or patient placed under court protection, guardianship or curatorship
• Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICI	Vascular investigation	Patients under ICI treatment for their cancer will have vascular investigation and biological assessment

Primary Outcome Measures

Name	Time	Method
Increasing of aortic arterial stiffness	42 days	Difference of aortic arterial stiffness between 42 days after inclusion and inclusion

Secondary Outcome Measures

Name	Time	Method
Overall survival	one year	Time between death and inclusion

Trial Locations

Locations (2)

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHU Rouen; 🇫🇷 Rouen, France