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 diagnosed with squamous cell carcinoma (a type of cancer) in the head and neck area who have already received 2 to 4 cycles of chemotherapy and immunotherapy, and whose medical team has recommended radiation treatment rather than surgery (either to preserve organ function, or because the patient has chosen not to have surgery)
• People aged 18 to 75 years old
• People whose head and neck cancer has been confirmed by a tissue biopsy
• People whose cancer is at a specific stage based on tumour size and lymph node involvement, with no spread to distant parts of the body (clinical stage T1-2N2-3M0 or T3-4N0-3M0 according to AJCC 8th edition) (confirm with trial site)
• People whose cancer tests negative for HPV and P16
• People who are fully active or have only minor restrictions on physical activity (ECOG performance score of 0 or 1) (confirm with trial site)
• People who have no medical reasons preventing them from receiving immunotherapy or radiation therapy
• People whose blood, liver, kidney, and heart test results meet specific healthy ranges set by the trial — including normal or near-normal levels of blood cells, liver enzymes, kidney function, clotting, and heart muscle markers (confirm with trial site for exact values)
• Women who could become pregnant must have had a negative pregnancy test within 7 days before joining, and both male and female participants must be willing to use reliable contraception during treatment and for 2 months afterwards
• People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments

Who may not be able to join:

• People who currently have, or have previously had, another cancer that has not been fully cured — with exceptions for certain low-risk cancers such as basal cell skin cancer, early-stage cervical cancer, papillary thyroid cancer, and superficial bladder cancer
• People who have an active autoimmune disease or a history of autoimmune conditions (such as certain types of lung, eye, bowel, liver, or kidney inflammation, thyroid disorders, or heart vessel inflammation) — though some exceptions may apply, such as people with vitiligo or well-controlled thyroid conditions (confirm with trial site)
• People with serious or uncontrolled heart problems, including significant heart disease, poorly controlled abnormal heart rhythms, weak heart pumping function, or a heart attack within the past year
• People who have an active infection or an unexplained fever above 38.5°C at the time of screening or before the first treatment (unless the fever is judged by the doctor to be caused by the cancer itself)
• People with a weakened immune system due to a condition present from birth or acquired (such as HIV), or people with active hepatitis B or hepatitis C infection
• People who have previously been treated with PD-1 or PD-L1 immunotherapy drugs
• People with a known allergy to cisplatin, large-molecule protein-based medicines, or any ingredient in the anti-PD-1 antibody used in this trial
• People who have recently had major surgery unrelated to cancer treatment and have not yet fully recovered from complications
• Women who are pregnant or currently breastfeeding
• People who, in the opinion of the trial investigator, have other serious medical, psychological, or social circumstances that could affect their safety or the reliability of the trial data

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