Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adalimumab 1200mg are administered intravenously. According to the allocation to the short-course group or long-course group, two or three cycles are carried out respectively, and surgery is performed 21 days after the end of the last cycle of medication. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive maintenance therapy with PD-L1 inhibitor (adalimumab) alone. Patients who require radiotherapy and chemotherapy receive maintenance therapy with the drug alone at the same time. The duration of medication for all patients is one year (calculated from the time of the first medication at the initial diagnosis to the last medication after the surgery).
Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg were administered intravenously. Two treatment courses were carried out in total, and surgery was performed 21 days after the end of the second course of medication. Postoperative radiotherapy and chemotherapy were administered based on the pathological stage. Patients who did not require radiotherapy received adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who required radiotherapy and chemotherapy received monotherapy maintenance during the same period. The duration of medication for all patients was one year (from the first medication time at the initial diagnosis to the last medication time after surgery).
Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg are administered intravenously. This treatment is carried out for a total of three cycles, and surgery is performed 21 days after the end of the third cycle. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who require radiotherapy and chemotherapy receive monotherapy maintenance simultaneously. The duration of medication for all patients is one year (from the first administration after diagnosis to the last administration after surgery).
Postoperative pathological complete response rate
There were no residual tumor cells in the pathological sections of the surgically resected primary lesion and lymph node specimens. The main judgment method is that the postoperative specimen is sent to the pathology department for fixation, sectioning, and observation. Two pathologists read the images to determine whether the tumor was residual. If there was any disagreement between them, the third senior pathologist would discuss and decide.
Time frame: All patients were treated within 7 working days after surgery
Major pathological response rate
Proportion of patients with 10% or less viable tumor cells in the primary lesion specimen.
Time frame: All patients were treated within 7 working days after surgery
Objective tumor response rate
Time frame: All patients were treated 21 days after the last dose of preoperative neoadjuvant immunochemotherapy
Event-free survival at 2 years
Time frame: Within 2 years after completion of all treatments
The overall survival rates for 2 years and 5 years
Time frame: Within the next 2 years and 5 years after all treatments are completed
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