Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy

Who cannot join

• 1. history of hypersensitivity to monoclonal antibodies; hypersensitivity to liposomal irinotecan; 2. use of a strong inducer of CYP3A4 within 2 weeks or a strong inhibitor of CYP3A4 or a strong inhibitor of UGT1A1 within 1 week prior to the first administration of the trial drug; 3. expected survival time < 3 months; 4. active hepatitis B (HbsAg or HBcAb positive and HBV DNA ≥ 2000 IU/mL), active hepatitis C (HCV antibody positive and HCVRNA above the lower limit of the study center's assay); if the patient has normal liver function and is taking concomitant antiviral medication, eligibility for enrollment will be determined by the investigator; 5. patients who are HIV antibody positive; and 6. active bacterial, fungal, viral, or interstitial pneumonia requiring systemic therapy within 1 week prior to the first dose of study drug; and 7. have received antineoplastic therapy such as chemotherapy, small molecule inhibitors, immunotherapy (e.g., interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives, whichever is shorter, but at least 2 weeks prior to the first dose of study drug; 8. treatment with a proprietary Chinese medicine with antitumor activity within 14 days prior to administration; treatment with another clinically investigational drug within 4 weeks prior to the first dose; 9. has undergone major surgery within 3 months prior to the first dose, or plans to undergo major surgery during the study period 10. has had a serious embolic event, e.g., cerebrovascular accident (including transient ischemic attack), pulmonary embolism, within 6 months prior to screening; 11. active malignancy within 2 years prior to the first study drug administration, with the exception of nasopharyngeal carcinoma, which is being studied in this trial, and any locally curable tumors that have undergone radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cardiac abnormalities including: carcinoma of the bladder, carcinoma of the cervix, or breast carcinoma in situ) 12. severe cardiovascular disease within 6 months prior to enrollment, including but not limited to the following:
• Acute myocardial infarction, unstable angina, coronary angioplasty or stenting, deep vein thrombosis, stroke; ② New York Heart Association class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) <50%; ③ Abnormal electrocardiograms (ECGs) of clinical significance at the time of screening, as assessed by the investigator; 13. women who are pregnant or breastfeeding; 14. any serious and/or uncontrollable medical condition, as determined by the investigator, other medical conditions that may interfere with the patient's participation in this study (including, but not limited to, uncontrolled diabetes mellitus, renal disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.);; and 15. other conditions judged by the investigator to be unsuitable for participation