Paclitaxel polymeric micelles 300 mg/m², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)
Age ≥18 and ≤75 years, male or female; Histologically or cytologically confirmed head and neck squamous cell carcinoma; Prior first-line systemic therapy (including chemotherapy, targeted therapy, and immunotherapy) with disease progression or judged by the clinician to no longer derive clinical benefit; ECOG performance status score of 0-2 and a life expectancy of at least 3 months; At least one measurable lesion on imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1, Appendix 3);
Known allergy or intolerance to any study treatment or any excipient; Presence of uncontrolled serious medical conditions, such as severe comorbidities including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; Other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery; Requirement for concomitant use of other antineoplastic drugs; Receipt of any other investigational drug or participation in another interventional clinical trial within 30 days prior to screening; History of psychotropic substance abuse with inability to abstain, or presence of psychiatric disorders; Pregnant or breastfeeding women; Patients deemed unsuitable for enrollment by the investigator.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead sponsor