Phase 3 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 oral squamous cell carcinoma (a type of mouth cancer) confirmed by a tissue biopsy.
• People whose cancer is locally advanced (has grown or spread to nearby lymph nodes but not to distant parts of the body) and where a surgeon at Wuhan University Hospital of Stomatology has assessed that surgery to remove the cancer is possible.
• People whose scans (chest CT and bone scan) show no signs of the cancer having spread to distant parts of the body.
• People whose blood tests and organ function results fall within the acceptable ranges required by the trial (covering blood cell counts, liver function, kidney function, thyroid, and blood clotting — confirm specific values with the trial site).
• People who are generally well enough to carry out light daily activities, with little or no limitation (known as ECOG performance status 0–1).
• Women who test negative for pregnancy within 7 days before starting the study treatment, and all participants (and their partners) must agree to use contraception throughout the study and for up to 120 days after the last dose of study treatment.
• People who understand what the study involves, including its requirements and risks, and are willing to sign a consent form.

Who may not be able to join:

• People who have previously had a serious (grade 3 or higher) immune-related side effect from a prior treatment, or whose immune-related side effects from a previous treatment have not yet settled down to a mild level.
• People who have had any prior cancer treatment — including surgery, chemotherapy, radiation therapy, or targeted therapy — within the past 5 years.
• People who have previously received certain types of immunotherapy drugs that work on immune checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 treatments).
• People with an active autoimmune disease, or a history of an autoimmune disease that was difficult to treat or control.
• People who currently have an active infection that requires treatment.
• People who are currently taking psychiatric medications or who have issues with alcohol or drug misuse.
• People who have another active cancer at the same time.
• People who have HIV, untreated active hepatitis B, or active hepatitis C, or who have received any vaccine (such as hepatitis B, flu, or chickenpox vaccines) within the 4 weeks before joining the trial.
• People with uncontrolled ongoing conditions such as diabetes or high blood pressure.
• People who have had a stroke or a mini-stroke (transient ischemic attack) within the past 6 months.
• People whose cancer has spread to distant parts of the body, or where a doctor has assessed that surgical removal is not possible.
• People with serious heart, lung, or immune system conditions, or other health issues that the research team believes could increase the risks of participating.

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