This is a prospective, randomized, controlled, multicenter, non-inferiority clinical study designed to evaluate the efficacy and safety of camrelizumab combined with EGFR monoclonal antibody or chemotherapy as perioperative treatment of locally advanced head and neck squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Camrelizumab 200 mg (Day 1) intravenous infusion (IV), Cetuximab Beta 400 mg/m² (Day 1) IV, followed by 250 mg/m² IV weekly, with a 21-day cycle for 2 cycles; followed by surgical treatment; with or without postoperative radiotherapy/chemoradiotherapy based on risk factors; then Camrelizumab 200 mg (Day 1) IV, with a 21-day cycle for up to 15 cycles.
Camrelizumab 200 mg (Day 1) intravenous infusion (IV) and Paclitaxel Albumin - bound 125 mg/m² (Day 1, Day 8) IV and Carboplatin AUC 4 (Day 1) IV, with a 21-day cycle for 2 cycles; followed by surgical treatment; with or without postoperative radiotherapy/chemoradiotherapy based on risk factors; then Camrelizumab 200 mg (Day 1) IV, with a 21-day cycle for up to 15 cycles.
2-year Overall Survival (OS) Rate
It is defined as the proportion of patients who remain alive at 2 years from the date of randomization, relative to the total number of patients in the group (Intention-to-Treat, ITT population).
Time frame: 2 years from the date of randomization
2-year Event-Free Survival (EFS) Rate
It is defined as the proportion of patients in the group (ITT population) who have not had an EFS event at 2 years from the start of randomization.
Time frame: 2 years from the date of randomization
Pathologic Complete Response (pCR) Rate
pCR rate is the proportion of patients in the ITT population of the group who achieve pCR. pCR means no tumor cell infiltration is found in the primary tumor specimen and all sampled regional lymph nodes.
Time frame: Within 1 month after surgery
Major Pathologic Response (MPR) Rate
MPR rate is the proportion of patients in the ITT population of the group who achieve MPR. MPR is defined as postoperative pathological examination showing ≤10% viable tumor in the tissue specimen, i.e., area of residual viable tumor cells / surface area of the tumor bed ≤10%, including the primary lesion and lymph nodes.
Time frame: Within 1 month after surgery
Objective Response Rate (ORR) assessed by RECIST 1.1
It is defined as the sum of the proportions of Complete Response (CR) and Partial Response (PR).
Time frame: Perioperative
3-year and 5-year Event-free Survival (EFS) Rates
They are defined as the proportions of patients in the group (ITT population) who have not had an EFS event at 3 years and 5 years from the start of randomization.
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Time frame: 3 years and 5 years from the start of randomization
3-year and 5-year Overall Survival (OS) Rates
They are defined as the proportions of patients in the group (ITT population) who are still alive and have no evidence of distant metastasis at 3 years and 5 years from the start of randomization.
Time frame: 3 years and 5 years from the start of randomization.
Quality of Life (QoL) Assessment by EORTC QLQ-C30
Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) . For functional scales and global health status/quality of life: higher scores indicate better status. For symptom scales: higher scores indicate worse symptoms.
Time frame: Perioperative
Quality of Life (QoL) Assessment by H&N35
Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head \& Neck 35 (H\&N35). Higher scores indicate more severe symptoms and poorer quality of life.
Time frame: Perioperative
Adverse Events (AEs)
Observed AEs will be evaluated with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, including type, incidence, severity, start and end time, whether it is an SAE, relationship to the study drug, and outcome.
Time frame: Baseline and Week 4