Status:
NOT_YET_RECRUITING
The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC)....
Eligibility Criteria
Inclusion
- Age: 18 to 70 years old.
- 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).
- Measurable Disease: At least one measurable primary lesion per RECIST 1.1 criteria.
- Treatment Status: Treatment-naïve patients with no prior therapy for the disease.
- Performance Status: ECOG performance status of 0-1.
- Surgical Eligibility: Deemed eligible for elective standard surgery followed by standard adjuvant chemoradiotherapy/radiotherapy, as assessed by the investigator.
- Autoimmune Disease: No active autoimmune diseases.
- Concurrent Malignancy: No concurrent malignancies.
- Life Expectancy: ≥6 months.
- Biomarker Testing: Available tumor tissue samples for PD-L1 testing via Combined Positive Score (CPS) using 22C3 pharmDx assay (DAKO).
- 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.
- Liver Function: ALT, AST, ALP, and total bilirubin ≤1.5× upper limit of normal (ULN).
- Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance \>60 mL/min.
- HPV Status: HPV status confirmed via p16 immunohistochemistry (IHC) and/or in situ hybridization (ISH).
- 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
- Cachexia or multiple organ failure.
- Active autoimmune disease(s) requiring systemic treatment (excluding vitiligo, resolved childhood asthma/atopy, or controlled hypothyroidism on hormone replacement).
- Concurrent second primary malignancy (e.g., esophageal cancer).
- Severe active infection requiring systemic therapy.
- 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.
- Dementia, altered mental status, or cognitive impairment affecting informed consent or questionnaire completion.
- Grade ≥2 peripheral neuropathy (per CTCAE v5.0).
- Grade ≥2 hearing impairment (per CTCAE v5.0).
- History of malignancy within the past 5 years (excluding cured non-melanoma skin cancer or carcinoma in situ).
- Known HIV-positive status or AIDS.
- Nasopharyngeal carcinoma or squamous cell carcinoma originating outside oral cavity, oropharynx, hypopharynx, or larynx (e.g., sinonasal tract, paranasal sinuses, or unknown primary).
- Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
- 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.
- Pregnancy, breastfeeding, or refusal of contraception by subjects of childbearing potential.
- Active infection requiring treatment or systemic antimicrobial use within 1 week prior to first dose.
- Live vaccines administered within 30 days before first dose or during the study.
- Vulnerable populations (e.g., severe psychiatric disorders, cognitive impairment, critically ill patients, prisoners, pregnant individuals).
- Other conditions deemed by the investigator to preclude safe study participation.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06895369
Start Date
May 1 2025
End Date
December 31 2033
Last Update
March 26 2025
Active Locations (1)
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1
Sir Run Run Shaw Hospital
Hanzhou, Zhejiang, China, 310016