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:

• You have been diagnosed with nasopharyngeal carcinoma (a type of cancer in the back of the nose/throat) confirmed by a lab test.
• Your cancer is considered "high-risk," meaning it meets at least one of these conditions: the cancer has spread to distant lymph nodes (but not to other organs); there are signs of significant spread into surrounding tissues like muscle, skin, or nerves; or a specific virus marker (EBV DNA) was still detectable in your blood after 2 rounds of pre-treatment chemotherapy.
• You are between 18 and 70 years old (any gender).
• You are generally active and able to carry out daily activities with little or no restriction (confirm with trial site).
• You have already completed 2–3 rounds of chemotherapy before radiation, as well as chemotherapy given alongside radiation therapy.
• Your blood, liver, and kidney test results are within acceptable ranges, without needing blood transfusions or growth factor support in the 14 days before joining.
• If you are a woman who could become pregnant, you must have a negative pregnancy test during screening.
• You are willing and able to give written consent to take part.

Who may not be able to join:

• Your nasopharyngeal cancer has come back after previous treatment or has spread to distant parts of the body.
• You have been diagnosed with another cancer in the last 5 years (except certain fully cured skin or cervical cancers).
• You have previously had radiotherapy or any other cancer treatment (including experimental treatments) for nasopharyngeal cancer.
• You have previously been treated with a type of immunotherapy drug called an anti-PD-1 antibody.
• You have an active autoimmune disease (where your immune system attacks your own body) or a history of one that could come back — though some well-controlled conditions like Type 1 diabetes, an underactive thyroid managed with hormone replacement, controlled celiac disease, or certain skin conditions not needing systemic treatment may still be acceptable (confirm with trial site).
• You have needed high-dose steroid tablets or other immune-suppressing medicines in the 14 days before joining — though low-dose, topical, inhaled, or short-course steroids for non-immune conditions may be acceptable (confirm with trial site).
• You have a history of serious lung disease such as lung scarring (pulmonary fibrosis), inflammation of the lung tissue, or other uncontrolled lung conditions.
• You currently have a serious active infection requiring antibiotic, antifungal, or antiviral treatment, or you had a severe infection (e.g., hospitalisation for infection or serious pneumonia) within the past 4 weeks, or took antibiotic tablets or IV antibiotics within the past 2 weeks.
• You have a known diagnosis of HIV.
• You have untreated or poorly controlled hepatitis B (with high virus levels in the blood) or active hepatitis C — though stable, treated hepatitis B or cured hepatitis C may still be acceptable (confirm with trial site).
• You have had a major operation requiring general anaesthetic within the past 28 days.
• You have previously had a stem cell transplant or organ transplant from a donor.
• You have had any of the following heart or blood vessel problems recently: significant cardiac chest pain in the last 28 days; a blood clot in the lungs in the last 28 days; a heart attack in the last 6 months; severe heart failure in the last 6 months; a serious heart rhythm problem in the last 6 months; a stroke in the last 6 months; uncontrolled high blood pressure despite medication in the last 28 days; or a fainting episode or seizure in the last 28 days.
• You have had a severe allergic reaction to the study drugs (toripalimab or capecitabine) or their ingredients.
• You have used any herbal medicines intended to treat cancer within the past 14 days.
• You still have significant side effects from previous cancer treatments that have not returned to normal or stabilised.
• You are currently taking part in another treatment-based clinical trial.
• You have a significant emotional disturbance or mental illness (confirm with trial site).
• You are unwilling or unable to sign the consent form.

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