A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination with Albumin-bound Paclitaxel with Cisplatin for Neoadjuvant and Adjuvant Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma
The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
• Age 18-75 years, male or female; Patients with primary stage III-IVa surgically resectable squamous cell carcinoma of the oral cavity with measurable lesions (≥10 mm on spiral CT scan, fulfilling RECIST 1.1 criteria) as confirmed by pathohistology; ECOG score of 0 or 1; Expected survival ≥ 12 weeks; Tumour tissue (paraffin specimen or fresh tumour tissue less than 2 years old) for PD-L1 detection is available; Organ function levels must meet the following requirements (14 days prior to first dose of study drug) Bone Marrow:Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelet (PLT) ≥ 100 x 109/L, Haemoglobin (HB) ≥ 9g/dL (no blood transfusion or receipt of component blood within 14 days prior to the test); Liver: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (if there is hepatic metastasis, AST and ALT are allowed to be ≤ 5 times the upper limit of normal); and Kidney: blood creatinine level less than 1.5 times the upper limit of normal or creatinine clearance ≥60ml/min, urea nitrogen ≤200mg/L; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be enrolled) Urine protein ≤1+, if urine protein \>1+, 24-hour urine protein measurement should be collected, and its total amount should be ≤1g; and Normal cardiac function, i.e. normal ECG or abnormalities without clinical significance and left ventricular ejection fraction (LVEF) \>50% on cardiac ultrasound.
• Reproductively active female subjects must have a negative serum pregnancy test prior to the first dose of the test drug.
• Reproductively active male or female subjects must be using a highly effective method of contraception (e.g., oral contraceptive pill, intrauterine device, abstinence from sexual intercourse, or barrier method of contraception combined with spermicide) throughout the course of the trial and continue to use contraception for 90 days after completion of treatment; Subjects volunteered to join the study, signed an informed consent form, were compliant and co-operated with follow-up visits.