Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
Trial Parameters
Brief Summary
This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck.
Eligibility Criteria
Inclusion Criteria: * Age: ≥ 18 years, male or female; * Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx) (SCCHN); * Recurrent/metastatic SCCHN not suitable for local treatment such as surgery or radiotherapy in the opinion of the investigator; * At least one measurable tumor lesion according to RECIST 1.1 criteria; * The tumor expresses PD-L1, with a comprehensive positive score CPS ≥ 1; * Eastern Cooperative Oncology Group (ECOG) PS: 0-1 * Expected survival ≥ 3 months; * Normal function of major organs, meeting the following criteria: blood routine examination criteria must be met: (no blood transfusion within 14 days before screening) 1) HB ≥ 90 g/L; 2) ANC ≥ 1.5 × 109/L; 3) PLT ≥ 75 × 109/L; biochemistry: (without transfusion or blood product within 14 days before screening) 1) BIL ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN for patients with Gilbert's syndrome); 2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patient