A Prospective Study of Pembrolizumab Combined with Chemotherapy (cisplatin or Carboplatin + Albumin-bound Paclitaxel) in First-line Therapy for Patients with Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma
• Voluntarily sign written informed consent before screening;
• Age 18\
‣ 75 years old;
• ECOG physical status score 0-1 points;
• Head squamous cell carcinoma (HNSCC) diagnosed by histology or cytology, the primary site is oral cavity, oral cavity Throat, lower throat or throat;
• Recurrent and/or metastatic HNSCC without indications for local radical treatment;
• According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one measurable lesion, right For lesions that have received radiotherapy in the past, only if there is clear disease progression 3 months after the end of radiotherapy, can it be Was selected as the target lesion;
• There are a large number of tumor tissue samples for PD-L1 immunohistochemical detection;
• The expected survival period exceeds 3 months;
• The main organs function normally, that is, they meet the following standards:
• I. Blood routine (not receiving blood transfusion 14 months before screening examination, erythropoietin (EPO), granulocyte set Fall stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) treatment): neutral Granulocyte ≥1.5×l09
⁃ L, platelets ≥100×109
⁃ L, hemoglobin≥90g/L; ii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ 3 for those without liver metastasis ×ULN, ALT and AST for liver metastases≤5×ULN; total bilirubin (TBIL)≤1.5×ULN (Gilbert Syndrome patients, ≤3×ULN); iii. Renal function: Serum creatinine (Cr)≤1.5×ULN or tendon clearance (Ccr)≥50ml/min (connect Residues treated with carboplatin) or ≥60ml/min (residuals treated with cisplatin); iv. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), thrombin Original time (PT)≤1.5×ULN; v. Heart echocardiogram: left ventricular ejection fraction (LVEF) ≥50%;
⁃ Women should agree to use contraceptive measures (such as intrauterine birth control) during the study period and within 6 months after the study ends.
‣ Device \[IUD\], contraceptive pill or condom); 7 diabetes blood pregnancy test was negative before study enrollment, and it must be non-Breastfeeding patients; males should agree to use contraceptive measures during the study period and within 6 months after the end of the study period patient.