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:

• People who have been diagnosed with a specific type of nasopharyngeal cancer (a non-keratinizing cancer of the back of the nose/throat, known as WHO type II or III) confirmed by a tissue sample.
• People whose cancer has been staged as stage III or IVA (using a standard staging system called AJCC 8th edition), except for one specific sub-stage (T3N0).
• People whose cancer showed a complete disappearance of the tumour — confirmed by MRI, PET-CT scan, and a tissue biopsy — and whose blood test for a virus linked to this cancer (EBV DNA) showed no detectable levels, after completing 3 cycles of chemotherapy combined with immunotherapy.
• People who are generally well enough to carry out normal daily activities, with only minor limitations (measured on a standard scale called ECOG, score of 0 or 1).
• People whose blood counts are within acceptable ranges: sufficient white blood cells, red blood cells (haemoglobin), and platelets.
• People whose liver and kidney function tests are within acceptable ranges, as measured by standard blood tests.
• People who have been fully informed about the nature of the study and have provided written consent to participate.

Who may not be able to join:

• People whose cancer did not fully disappear, or whose EBV DNA blood test was still detectable, after 3 cycles of induction chemotherapy plus immunotherapy.
• People whose blood test results do not meet the required standards within 7 days before enrolment.
• People who have previously received chemotherapy, immunotherapy, targeted therapy, or surgery for this cancer (other than a diagnostic procedure).
• People who have previously been treated with certain types of immunotherapy drugs that target immune checkpoints (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies) or drugs that target blood vessel growth.
• People who have active cancer that has spread to the brain or spinal cord, with ongoing symptoms or requiring steroid treatment.
• People who have had significant nosebleeds requiring medical treatment, or coughed up meaningful amounts of blood, within the month before enrolment.
• People with uncontrolled high blood pressure (above 140/90 mmHg despite medication), significant heart disease, certain heart rhythm problems, or heart failure.
• People currently taking blood-thinning or anti-clotting medications such as warfarin, heparin, high-dose aspirin, or similar drugs (confirm with trial site regarding whether stopping these medications 10 days before starting the study may allow enrolment).
• People who have or have had another type of cancer, with some exceptions such as certain treated skin cancers, treated cervical cancer, localised prostate cancer, or ductal carcinoma in situ.
• People with a known history of interstitial lung disease (scarring or inflammation of the lungs).
• People with a known allergy to any ingredient in the immunotherapy drugs used in the study.
• People with a known allergy to any of the chemotherapy drugs used in the study (gemcitabine, cisplatin, docetaxel, abraxane, or paclitaxel).
• People with active autoimmune diseases or conditions that require ongoing steroid or immune-suppressing treatment (some exceptions may apply — confirm with trial site).
• People who require long-term use of immune-suppressing medications.
• People who are HIV positive, have active hepatitis B with detectable virus levels, or have chronic hepatitis C confirmed by blood testing.
• People with a known history of active tuberculosis within the past year, or who are currently on or recently completed tuberculosis treatment.
• People who have received a live vaccine, steroid treatment, or any anti-infection vaccine, or have taken Chinese herbal anti-tumour medicines within 4 weeks before enrolment.
• People who are pregnant or breastfeeding.
• People considered unsuitable by their treating doctor for reasons not listed above.

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