Efficacy and Safety of Paclitaxel Polymeric Micelles in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Exploratory Phase II Clinical Study
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);
⁃ Adequate major organ function, with subjects meeting the following laboratory parameters:
⁃ Complete blood count meeting the following criteria (no blood transfusion, blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to the test): WBC ≥3.0×10\^9/L, ANC ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L; Blood biochemistry meeting the following criteria: total bilirubin ≤1.5×ULN, AST, ALT, or ALP ≤2.5×ULN (for subjects with liver metastases, ALT, AST, or ALP ≤5×ULN is permitted; for subjects with bone metastases, ALP ≤10×ULN is permitted); serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula, Appendix 4) ≥50 mL/min; Adequate coagulation function, defined as INR ≤1.5×ULN and PT or APTT ≤1.5×ULN; Subjects of childbearing potential must agree to use highly effective contraceptive measures during the trial. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of chemotherapy; Good compliance, able to undergo treatment and follow-up, and willing to comply with the study requirements; voluntary signing of the informed consent form.