A Single Arm, Exploratory Clinical Study of the Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma in Clinical Practice
The goal of this \[type of study:clinical trial\] is to \[learn about\] in \[Clinical IVB stage oral squamous cell carcinoma patients\]. The main question it aims to answer are: • \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, with a total follow-up of two years.\].
• Oral squamous cell carcinoma patients diagnosed by histology or cytology;
• Has not received any treatment for oral squamous cell carcinoma in the past;
• According to the AJCC TNM staging system, stage clinical IVB;
• ECOG score: 0-1 points;
• Expected survival time ≥ 12 weeks;
• The main organ function is good, and the laboratory test data meets the following standards: (1) Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal values in the research center laboratory), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times the ULN. If the patient has liver metastasis, this standard is ≤ 5 times the ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to Cockcroft Gault formula);
• Female participants with fertility, as well as male participants with partners who are fertile women, are required to use a medically recognized contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period, and at least 6 months after the last use of adelbizumab and at least 6 months after the last use of chemotherapy;
• Voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.