Patients with histologically or cytologically confirmed stage III-IVB head and neck squamous cell carcinoma (oral cavity, p16-negative oropharynx, larynx, or hypopharynx), with tumor tissue testing showing PD-L1 CPS >=1 by immunohistochemistry and EGFR positivity.
Conditions
Interventions
Single-arm:Neoadjuvant therapy
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Histologically or cytologically confirmed Stage III-IVB head and neck squamous cell carcinoma (oral cavity, p16-negative oropharynx, larynx, or hypopharynx), with tumor tissue testing showing PD-L1 CPS >=1 by immunohistochemistry and EGFR positivity; 3.Planned to receive immune-combined neoadjuvant therapy; 4.No prior antitumor therapy for HNSCC; 5.Patients must meet at least one of the following criteria for platinum-based chemotherapy ineligibility: Age >70 years; Renal dysfunction (creatinine clearance rate =25 dB shift at two consecutive frequencies); Inability to tolerate intravenous hydration due to cardiac dysfunction or other comorbidities (investigator’s judgment); Grade >1 neuropathy; Patient refusal of chemotherapy; 6.ECOG PS score 0-2 or KPS score >=60; 7.Adequate cardiac function with left ventricular ejection fraction (LVEF) >=50%; 8.At least one measurable lesion per RECIST v1.1 criteria; 9.Oropharyngeal cancer patients must provide tumor tissue for HPV/p16 testing (if previously tested, retesting is not required); 10.Expected survival time =6 months; 11.Adequate hematologic function: White blood cell count >=4×10^9/L; Absolute neutrophil count >=1.5×10^9/L; Platelets >=100×10^9/L; Hemoglobin >=90 g/L; 12.Adequate renal function: Serum creatinine 50 mL/min (calculated using Cockcroft-Gault formula): Female CrCl = (140 – age) × weight (kg) × 0.85 / (72 × Scr mg/dL) Male CrCl = (140 – age) × weight (kg) × 1.00 / (72 × Scr mg/dL); 13.Adequate hepatic function: Total bilirubin <=1.5×ULN; AST <=2.5×ULN; ALT <=2.5×ULN; 14.For women of childbearing potential: Negative pregnancy test within 2 weeks before study treatment initiation; Must be non-lactating; Must agree to use effective contraception during the study and for 6 months after the last dose. Male participants must agree to use effective contraception during the study and for 6 months after the last dose; 15.Patients must voluntarily participate, provide written informed consent, and comply with study visits and procedures;
Exclusion criteria
Exclusion criteria: 1.Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo may be included; childhood asthma that has completely resolved without intervention in adulthood may be included; asthma requiring bronchodilator treatment is excluded); 2.Current use of immunosuppressive agents or systemic corticosteroids (at doses >10 mg/day prednisone or equivalent) for immunosuppressive purposes, with continued use within 2 weeks prior to enrollment; 3.Prior treatment with PD-1/PD-L1 inhibitors, EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or anti-angiogenic drugs; 4.Presence of any severe and/or uncontrolled medical conditions, including: Poorly controlled hypertension (systolic BP =150 mmHg or diastolic BP =100 mmHg); Grade =1 myocardial ischemia,myocardial infarction, arrhythmia (including QTc interval =480 ms), or Grade 1 cardiac insufficiency; Active or uncontrolled severe infections; Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA =104 copies/mL or 2000 IU/mL), or hepatitis C (HCV antibody-positive with HCV-RNA above the lower limit of detection); 5.Imaging evidence of tumor invasion into major blood vessels or investigator’s judgment that the tumor is likely to invade major vessels, posing a risk of life-threatening hemorrhage during the study. 6.Pregnant or breastfeeding women; 7.History of other malignancies within the past 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ); 8.History of drug abuse or inability to discontinue psychoactive substances, or patients with psychiatric disorders; 9.Participation in another investigational drug trial within 4 weeks prior to enrollment; 10.Any concurrent condition that, in the investigator’s judgment, poses a significant risk to patient safety or compromises study completion; 11.Known hypersensitivity to any component of the study drugs; 12.Unwillingness to participate or inability to provide informed consent; 13.Any other condition deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival, local recurrence free survival, distant metastasis free survival;Overall survival;Major pathologic remission rate of surgical patients,MPR rate;Life quality;Safety;R0 rate of surgical patients;Pathologic complete remission rate of surgical patients,pCR rate; | — |
Countries
China
Contacts
Public ContactSun Yan
Beijing Cancer Hospital
Outcome results
None listed