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 a local return of their cancer, with or without spread to nearby lymph nodes, at least 1 year after completing their original radical treatment
• People whose cancer cannot be treated with surgery
• People whose cancer has been confirmed by tissue biopsy as nasopharyngeal carcinoma (a type of throat cancer), specifically WHO Type II or III
• People whose cancer is at a certain stage of recurrence (stages rII to IVa, based on the AJCC/UICC 8th edition staging system) (confirm with trial site)
• People who have a good general level of physical fitness and are able to carry out daily activities with little or no limitation (ECOG score of 0 or 1)
• People who have not yet received any treatment — such as radiation, chemotherapy, immunotherapy, or biological therapy — for their returned cancer
• People who have no medical reasons preventing them from receiving immunotherapy or combined radiation and chemotherapy
• People whose blood cell counts are within acceptable ranges, indicating healthy bone marrow function (confirm with trial site for specific values)
• People whose liver function test results are within acceptable ranges (confirm with trial site for specific values)
• People whose kidney function is within acceptable ranges (confirm with trial site for specific values)
• People who are willing and able to use effective contraception during treatment and for two months after treatment ends
• People who have been fully informed about the nature of the study and are willing to provide written consent to participate

Who may not be able to join:

• People who have been treated with anti-cancer traditional Chinese medicine
• People whose cancer has returned in an area where tissue has broken down or died (local necrosis)
• People who have moderate to severe lasting side effects (Grade 3 or higher) from previous treatment, except those affecting the skin, tissue under the skin, or mucous membranes
• People who have an unexplained fever above 38.5°C that is not caused by the tumour itself
• People who have taken antibiotics for 5 or more days in the month before enrolling
• People who have an active autoimmune disease (such as certain eye, gut, liver, hormonal, kidney, blood vessel, or severe breathing conditions)
• People who have a known diagnosis of HIV, active Hepatitis B at certain levels, or a positive Hepatitis C antibody result
• People who have previously been treated with PD-1 antibody therapy or similar immunotherapy drugs that target the PD-1/PD-L1 pathway
• People with significant heart problems, including severe heart failure, unstable chest pain, a heart attack within the past year, or a serious irregular heartbeat requiring treatment
• People with a known allergy to large protein-based medicines or any component of the study treatment
• People who are pregnant or breastfeeding
• People who have had a previous cancer, except for certain treated skin cancers, early-stage cervical cancer, or papillary thyroid cancer
• People who have received a live vaccine within 30 days before the planned start of the study treatment
• People with a psychiatric condition or substance use disorder that could interfere with their ability to take part in the trial
• People with any other condition — including mental health concerns or personal or social circumstances — that the trial doctor believes would make it difficult to participate safely or meaningfully

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