Phase 2 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 are willing to take part, sign a consent form, and follow all study visits, treatments, and tests as required.
• People aged 18 years or older.
• People who have been diagnosed with nasopharyngeal carcinoma (a type of head and neck cancer) confirmed by a tissue biopsy, specifically the differentiated or undifferentiated non-keratinous type.
• People whose nasopharyngeal carcinoma has come back or spread, and who have already tried at least one course of treatment involving an anti-PD-1/L1 immunotherapy drug (for at least 6 weeks), and whose cancer either progressed during that treatment or returned within a certain time after finishing it.
• People whose cancer has returned or spread and cannot be treated with surgery or radiotherapy aimed at curing the disease.
• People who have at least one tumour that can be measured on a scan, meeting specific size requirements set by the trial.
• People who are reasonably active and able to care for themselves, as measured by a standard medical scoring system (ECOG score of 0 or 1), and who are expected to live for at least 3 months.
• People whose liver, kidney, and blood counts meet the minimum levels required by the trial, as confirmed through blood tests.

Who may not be able to join:

• People who have had a severe allergic reaction to irinotecan liposome (the study drug), such as a serious rash, low blood pressure, breathing difficulties, or anaphylaxis.
• People who have taken certain medications that strongly affect how the body processes drugs (CYP3A4 strong inducers within 2 weeks, or CYP3A4/UGT1A1 strong suppressors within 1 week) before starting the trial (confirm with trial site).
• People with an expected survival of less than 3 months.
• People with certain active hepatitis B or hepatitis C infections, unless a doctor determines their liver function is normal and they are already receiving appropriate antiviral treatment.
• People who are HIV-positive.
• People who have an active bacterial, fungal, or viral infection, or a lung condition called interstitial pneumonia, that requires treatment within 1 week before starting the trial.
• People who have received chemotherapy, targeted therapy, immunotherapy, or any other experimental cancer treatment within 4 weeks (or 5 half-lives of the drug, whichever is shorter, but at least 2 weeks) before starting the trial.
• People who have taken Chinese herbal medicines with anti-cancer properties within 14 days, or other experimental drugs within 4 weeks, before starting the trial.
• People who have had major surgery within 3 months before starting the trial, or who are expected to need major surgery during the study.
• People who have had a serious blood clot-related event — such as a stroke, mini-stroke, or pulmonary embolism — within 6 months before joining.
• People who have been diagnosed with or treated for another type of cancer within the past 2 years, unless it was a type that has been fully cured (such as certain skin cancers, early cervical cancer, or papillary thyroid cancer).
• People who have had serious heart conditions within the 6 months before joining, including heart attack, unstable chest pain, certain heart procedures, deep vein blood clots, stroke, severe heart failure, or a significantly abnormal heart trace on an ECG.
• People who are pregnant or breastfeeding.
• People with serious or uncontrolled health conditions affecting the heart, lungs, liver, kidneys, or other vital organs, including uncontrolled diabetes, severe autoimmune conditions, bleeding disorders, substance misuse, or neurological disorders.
• People who the trial doctors determine are otherwise not suitable to participate, for any reason.

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