Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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 are willing to take part and sign a consent form agreeing to participate.
• People aged between 18 and 70 years, who are male or female and not pregnant.
• People who have been confirmed by a tissue test to have a specific type of nasopharyngeal cancer (a cancer at the back of the nose/throat), classified as WHO Type II or III (non-keratinizing type).
• People whose cancer has spread to certain nearby lymph nodes or nearby structures, but has not spread to distant parts of the body — based on a specific cancer staging system (9th AJCC/UICC).
• People who are generally well enough to carry out everyday activities, with only minor limitations (rated 0 or 1 on a standard health performance scale).
• People whose blood counts meet minimum levels: enough red blood cells, white blood cells, and platelets (confirm with trial site for exact values).
• People whose liver is functioning well enough, based on blood test results within accepted limits.
• People whose kidneys are functioning well enough, based on a calculation of how well the kidneys filter waste.
• People who are sexually active and able to have children must be willing to use effective contraception throughout treatment and for one year after the last dose of the study drug — this applies to both women who could become pregnant and men whose partners could become pregnant.

Who may not be able to join:

• People who are younger than 18 or older than 70 years of age.
• People whose cancer has come back after previous treatment or has spread to distant parts of the body.
• People whose tissue test confirms a different type of nasopharyngeal cancer, classified as WHO Type I (keratinizing squamous cell carcinoma).
• People who have previously had radiotherapy or chemotherapy for this condition.
• People who have a hepatitis B infection with a high level of the virus detected in their blood.
• People who test positive for hepatitis C antibodies.
• People who have an active autoimmune disease (a condition where the immune system attacks the body), with some exceptions such as well-controlled type 1 diabetes, thyroid conditions managed with standard medication, or certain skin conditions that do not need full-body treatment.
• People who have needed high-dose steroid medication or other immune-suppressing treatments within the 28 days before signing the consent form (lower-dose steroids, inhaled steroids, or skin-applied steroids may be acceptable — confirm with trial site).
• People who have had an active tuberculosis infection within the past year.
• People who have a known history of a lung condition called interstitial lung disease.
• People who have received a live vaccine within 30 days before signing the consent form, or who are expected to need one soon.
• People who are currently pregnant or breastfeeding.
• People who have had another cancer diagnosed within the past five years, with some exceptions such as certain skin cancers and a specific type of thyroid cancer (confirm with trial site).
• People who are known to be allergic to toripalimab (the study drug) or similar large protein-based medicines.
• People who are known to have HIV infection.
• People with serious heart conditions, active infections needing treatment, significant mental health conditions, or other circumstances that the trial doctor believes would make participation unsafe or interfere with the study.

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