Paclitaxel polymeric micelles with carboplatin in adults with recurrent/metastatic head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial enrolls adults 18–75 with recurrent or metastatic head and neck squamous cell carcinoma who have progressed after initial therapy. Participants receive paclitaxel polymeric micelles at 300 mg/m² IV over at least 3 hours plus carboplatin AUC 5 IV on Day 1, every 3 weeks for up to 3 cycles, with possible extension if there is no disease progression and tolerable toxicity. Efficacy is assessed after cycle 3, and treatment may continue until progression, unacceptable toxicity, withdrawal, or other protocol criteria. Safety and effectiveness will be monitored through standard imaging and laboratory tests per protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yue He, M.D. — the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
• Study coordinator: Guoxin Ren
• Email: renguoxincn@sina.com
• Phone: 13916948812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.