Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with cancer of the nasal cavity or sinuses, confirmed by laboratory testing of tissue or cells, and the cancer type must be squamous cell carcinoma (including certain variations) or sinonasal undifferentiated carcinoma (SNUC).
• People whose cancer has been assessed by their surgical team as removable by surgery (for squamous cell carcinoma), or removable or borderline removable (for SNUC).
• People whose cancer has reached a certain stage of spread within the local area — specifically stages III, IVA, or IVB based on tumour size and lymph node involvement, with no spread to distant parts of the body (confirm with trial site for exact staging details).
• People who are willing to provide blood and tissue samples before treatment and at the time of surgery for research purposes.
• People aged 18 or older at the time of signing the consent form.
• People who are generally fit and able to carry out daily activities, rated 0 or 1 on a standard performance scale used by doctors (confirm with trial site).
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (confirm with trial site for specific values).
• People who are able to use reliable contraception during the trial and for a period after the last dose of treatment — at least 6 months after the last chemotherapy dose for females, 3 months for males, and 4 months after the last dose of the immunotherapy drug (toripalimab) for both males and females.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People whose nasal cavity or sinus cancer is a different tumour type, such as angiosarcoma, rhabdomyosarcoma, lymphoma, olfactory neuroblastoma, melanoma, meningioma, or sinonasal neuroendocrine carcinoma (SNEC), among others.
• People whose cancer has been assessed by their surgical team as unable to be removed by surgery.
• People whose cancer has already spread to distant parts of the body.
• People who have previously been treated with certain immune-based therapies that target specific pathways in the immune system (such as anti-PD-1 or anti-PD-L1 treatments).
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the trial treatment.
• People who have a diagnosed condition affecting the immune system, or who have been taking high-dose steroid medications or other immune-suppressing treatments within 7 days before the first dose of trial treatment.
• People who have another cancer that is currently active or has required treatment within the past 2 years — though some exceptions may apply, such as certain treated skin cancers or carcinoma in situ (confirm with trial site).
• People who have an active autoimmune disease that has required systemic medical treatment in the past 6 months — though hormone replacement therapies such as thyroid or insulin treatment are generally not considered a barrier (confirm with trial site).
• People who have a history of non-infectious lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease) that required steroid treatment, or who currently have either of these conditions.
• People with uncontrolled HIV infection — those with well-controlled HIV may potentially be considered if certain blood and viral measures are favourable (confirm with trial site).
• People with active Hepatitis B or active Hepatitis C infection.
• People who have previously received a transplant of tissue or a solid organ from another person.
• People who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.