OncoMatch/Clinical Trials/NCT07662746
Efficacy and Safety of Paclitaxel Polymeric Micelles in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Official title: 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
Is NCT07662746 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Paclitaxel polymeric micelles for head and neck cancer.
Treatment: Paclitaxel polymeric micelles — 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.)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
recurrent/metastatic head and neck squamous cell carcinoma; At least one measurable lesion on imaging according to RECIST v1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy — first-line for 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
Lab requirements
Blood counts
WBC ≥3.0×10^9/L, ANC ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90 g/L
Kidney function
serum creatinine ≤1.5×ULN and creatinine clearance ≥50 mL/min
Liver function
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)
Adequate major organ function, with subjects meeting the following laboratory parameters: Complete blood count...Blood biochemistry...Adequate coagulation function, defined as INR ≤1.5×ULN and PT or APTT ≤1.5×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07662746 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages