The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC

Launched by SIR RUN RUN SHAW HOSPITAL · Mar 25, 2025

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 to 70 years old.
• • 2. Diagnosis: Histopathologically confirmed head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx, classified as Stage III or IV A according to the AJCC Cancer Staging Manual (8th Edition).
• • 3. Measurable Disease: At least one measurable primary lesion per RECIST 1.1 criteria.
• • 4. Treatment Status: Treatment-naïve patients with no prior therapy for the disease.
• • 5. Performance Status: ECOG performance status of 0-1.
• • 6. Surgical Eligibility: Deemed eligible for elective standard surgery followed by standard adjuvant chemoradiotherapy/radiotherapy, as assessed by the investigator.
• • 7. Autoimmune Disease: No active autoimmune diseases.
• • 8. Concurrent Malignancy: No concurrent malignancies.
• • 9. Life Expectancy: ≥6 months.
• • 10. Biomarker Testing: Available tumor tissue samples for PD-L1 testing via Combined Positive Score (CPS) using 22C3 pharmDx assay (DAKO).
• 11. Hematologic Parameters:
• • ANC ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥100 g/L, WBC ≥3.5×10⁹/L.
• • No transfusion within 7 days or bleeding tendency.
• • 12. Liver Function: ALT, AST, ALP, and total bilirubin ≤1.5× upper limit of normal (ULN).
• • 13. Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance \>60 mL/min.
• • 14. HPV Status: HPV status confirmed via p16 immunohistochemistry (IHC) and/or in situ hybridization (ISH).
• • 15. Informed Consent: Voluntarily participates and signs informed consent. For participants unable to consent due to incapacity, consent must be provided by a legally authorized representative. For illiterate participants, an impartial witness must attest to the informed consent process.
• Exclusion Criteria:
• • 1. Cachexia or multiple organ failure.
• • 2. Active autoimmune disease(s) requiring systemic treatment (excluding vitiligo, resolved childhood asthma/atopy, or controlled hypothyroidism on hormone replacement).
• • 3. Concurrent second primary malignancy (e.g., esophageal cancer).
• • 4. Severe active infection requiring systemic therapy.
• 5. Uncontrolled comorbid medical conditions that may compromise protocol compliance, per investigator judgment, including:
• • Severe cardiovascular/cerebrovascular diseases,
• • Uncontrolled diabetes/hypertension,
• • Active peptic ulcer,
• • Uncontrolled infections.
• • 6. Dementia, altered mental status, or cognitive impairment affecting informed consent or questionnaire completion.
• • 7. Grade ≥2 peripheral neuropathy (per CTCAE v5.0).
• • 8. Grade ≥2 hearing impairment (per CTCAE v5.0).
• • 9. History of malignancy within the past 5 years (excluding cured non-melanoma skin cancer or carcinoma in situ).
• • 10. Known HIV-positive status or AIDS.
• • 11. Nasopharyngeal carcinoma or squamous cell carcinoma originating outside oral cavity, oropharynx, hypopharynx, or larynx (e.g., sinonasal tract, paranasal sinuses, or unknown primary).
• • 12. Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
• • 13. Systemic glucocorticoids (\>10 mg/day prednisone equivalent) or immunosuppressive agents within 14 days prior to randomization.
• • • Exceptions: Inhaled/topical steroids or physiologic replacement doses for adrenal insufficiency.
• • 14. Pregnancy, breastfeeding, or refusal of contraception by subjects of childbearing potential.
• • 15. Active infection requiring treatment or systemic antimicrobial use within 1 week prior to first dose.
• • 16. Live vaccines administered within 30 days before first dose or during the study.
• • 17. Vulnerable populations (e.g., severe psychiatric disorders, cognitive impairment, critically ill patients, prisoners, pregnant individuals).
• • 18. Other conditions deemed by the investigator to preclude safe study participation.

Trial Officials