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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab and Cetuximab | Experimental | Camrelizumab (Day 1) and Cetuximab Beta (Day 1, Day 8, Day 15), 2 cycles |
|
| Camrelizumab and Chemotherapy | Active Comparator | Camrelizumab (Day 1), Paclitaxel Albumin - bound (Day 1, Day 8) and Carboplatin (Day 1), 2 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab and Cetuximab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years from the date of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years from the date of randomization |
| Pathologic Complete Response (pCR) Rate |
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Inclusion Criteria:
Subjects with pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal cancer);
Aged 18-75 years, of any gender
Subjects in clinical stage III-IVb (TNM staging, 8th edition); for oropharyngeal squamous cell carcinoma (P16-), the stage shall be III-IVb; for oropharyngeal squamous cell carcinoma (P16+), the stage shall be III.
Subjects with no prior anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy, or biotherapy for the current head and neck tumors;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Estimated survival time ≥ 6 months;
Subjects with no obvious contraindications to immunotherapy, chemoradiotherapy and surgery;
Subjects who are willing to undergo surgical treatment;
Subjects with major organ function levels meeting the following criteria:
Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and be willing to use effective methods of contraception during the study and for 6 months after the last dose of the anti-PD-1 antibody. For male subjects whose partners are women of childbearing potential, effective methods of contraception must be used during the study and for 6 months after the last dose of the anti-PD-1 antibody;
Subjects who voluntarily participate in this study, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue He, M.D. | Contact | +86-021-23271699-5154 | william5218@126.com | |
| Feng Liu, M.D. | Contact | +86-18917797783 | nuanliu@126.com |
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|
| Camrelizumab and Chemotherapy | Drug | 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. |
|
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. |
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | Baseline and Week 4 |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000068818 | Cetuximab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
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