Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial
This is a prospective, single-arm, Phase II clinical trial. The included population consisted of untreated patients with histologically confirmed stage I-II oral squamous cell carcinoma. Eligible patients received neoadjuvant low-dose radiotherapy combined with adibelizumab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy. The primary endpoints were the rate of pathological response and the rate of exemption from cervical lymph node dissection. The secondary endpoints included progression-free survival, local control rate, distant metastasis-free rate, overall survival, safety and quality of life of patients, as well as the exploration of biomarkers
• Patients aged 18 to 70, gender not limited;
• Confirmed by pathological examination as oral squamous cell carcinoma (anterior 2/3 of the tongue, floor of the mouth, gingiva, buccal mucosa, hard palate, posterior molar area);
• Diagnosed as stage I-II oral squamous cell carcinoma (T1-2N0M0) according to the 8th edition of the clinical staging system of the American Joint Committee on Cancer;
• ECOG 0-1 point;
• Vital organs function normally and can tolerate the prescribed treatment plan:
‣ There was no obvious abnormality in bone marrow hematopoietic function before treatment: white blood cell count ≥3.5×109/L, neutrophil count ≥2.0×109/L; Hemoglobin ≥100g/L Platelet count ≥100×109/L;
⁃ No obvious abnormalities were observed in liver and kidney functions before treatment: Total bilirubin ≤1.5 times the upper limit of normal; Aspartate aminotransferase and/or alanine aminotransferase ≤2.5 times the normal upper limit; Alkaline phosphatase ≤2.5 times the normal upper limit; Creatinine clearance rate ≥60 mL/min;
⁃ The examination results of thyroid function, coagulation function, pituitary function, inflammatory infection indicators, myocardial enzymes, electrocardiogram and echocardiography are normal;
• Women of childbearing age (18-49 years old) have negative serum or urine HCG tests within 7 days before treatment and agree to use medically approved contraceptive measures during the treatment period and within 120 days after the end of treatment;
• Sign the informed consent form, voluntarily participate in the clinical trial research project, and be willing and able to comply with the follow-up, treatment, laboratory testing and other research requirements stipulated in the research schedule.