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 through a biopsy or tissue sample with locally advanced squamous cell carcinoma (a specific type of cancer) in the head and neck area — including the mouth, throat, voice box, or lower throat — but not the lip or nasopharynx (the upper part of the throat behind the nose)
• People whose cancer has been treated with surgery aimed at fully removing the tumour, with a cancer stage of T1–4, N0–3, M0 (meaning the cancer has not spread to distant parts of the body), and who are planned to receive chemotherapy plus radiotherapy after surgery
• People whose situation after surgery includes at least one of the following: cancer cells found at or very close to the surgical cut edge, more advanced cancer staging after surgery (pT3–4 or pN2–3), cancer spread to certain lymph nodes in the lower neck (levels IV or V), or cancer that has grown into nearby nerves, blood vessels, or lymphatic vessels
• People who are generally well enough to carry out daily activities with little or no limitation (rated 0 or 1 on a standard activity scale)
• People whose blood test results show healthy levels of red blood cells, white blood cells, and platelets, without having received a blood transfusion in the 14 days before testing
• People whose liver and kidney function tests are within acceptable ranges as determined by the trial
• Women who could become pregnant must have a negative pregnancy test (blood or urine) within 7 days before joining, and must agree to use reliable contraception during the trial and for 8 weeks after the last dose of the study drug
• Men must agree to use reliable contraception during the trial and for 8 weeks after the last dose of the study drug, or have had a surgical procedure that prevents them from fathering a child
• People who voluntarily agree to take part and sign the informed consent form

Who may not be able to join:

• People whose biopsy confirms a type of cancer other than squamous cell carcinoma
• People whose cancer has come back or has spread to distant parts of the body
• People who have previously received chemotherapy for any reason, or who have had surgery, radiotherapy, targeted therapy, or immunotherapy (such as anti-PD-1 or anti-PD-L1 treatments) in the head and neck area
• Women who are pregnant or breastfeeding
• People who have had, or currently have, another type of cancer
• People with other serious medical conditions that are not under control
• People with significant heart, brain, or lung problems — including high blood pressure that cannot be managed with medication, heart disease, irregular heartbeat, heart failure, a stroke or major heart event in the past 6 months, blood clotting problems, a tendency to bleed, or significant protein in the urine
• People with an active infection that requires ongoing treatment throughout the body, such as tuberculosis
• People who have previously had a bone marrow or stem cell transplant
• People known to have HIV infection
• People with active hepatitis B that is not being treated, or active hepatitis C infection (confirm with trial site for specific testing thresholds that may allow some hepatitis B cases to be considered)
• People with a history of substance abuse they are unable to stop, or a mental health condition that may affect their ability to participate
• People who are allergic to the study drug or any of its ingredients
• People currently taking part in another treatment-based clinical trial
• People where the trial doctors determine that participation would not be appropriate for any other reason

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