Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Randomized Controlled Trial of Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

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 Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Camrelizumab and Cetuximab; Drug: Camrelizumab and Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yue He, M.D.; Phone Number: +86-021-23271699-5154; Email: william5218@126.com
• Study Contact Backup: Name: Feng Liu, M.D.; Phone Number: +86-18917797783; Email: nuanliu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects with pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal cancer);
2. Aged 18-75 years, of any gender
3. 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.
4. Subjects with no prior anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy, or biotherapy for the current head and neck tumors;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
6. Estimated survival time ≥ 6 months;
7. Subjects with no obvious contraindications to immunotherapy, chemoradiotherapy and surgery;
8. Subjects who are willing to undergo surgical treatment;

9. Subjects with major organ function levels meeting the following criteria:

   1. Hematology must meet the following criteria: White blood cell (WBC) count ≥4.0×10^9/L, absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet (PLT) count ≥100×10^9/L, hemoglobin (Hb) ≥90 g/L (no blood transfusion or blood products within 14 days, and no correction with granulocyte-colony stimulating factor (G-CSF) or other hematopoietic stimulating factors);
   2. Blood chemistry must meet the following criteria: Serum albumin ≥ 3.0 g/dL (30 g/L), total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, blood urea nitrogen (BUN) and creatinine (CRE) ≤1.5×ULN or endogenous creatinine clearance ≥60 mL/min (Cockcroft-Gault formula);
   3. Good coagulation function: Defined as an international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; if the subject is receiving anticoagulant therapy, the PT must be within the intended therapeutic range for the anticoagulant drug;
10. 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;
11. Subjects who voluntarily participate in this study, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.

Exclusion Criteria:

1. Subjects who have received prior treatment with anti-PD-1/programmed death-ligand 1 (PD-L1) antibodies, anti-programmed death-ligand 2 (PD-L2) antibodies, anti-cluster of differentiation 137 (CD137) antibodies, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways;
2. Subjects with a severe, active autoimmune disease. Subjects in a stable condition who do not require systemic immunosuppression are allowed to be enrolled, such as those with: Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia);
3. Subjects with congenital or acquired immunodeficiency (e.g., human immunodeficiency virus (HIV) infection), active hepatitis B (hepatitis B virus (HBV)-DNA ≥10^4 copies/mL), or active hepatitis C (hepatitis C antibody positive, and HCR-RNA above the lower limit of detection of the analytical method);
4. Subjects with known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.
5. Subjects with the following conditions within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, cardiac insufficiency of NYHA Class II or higher, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure.
6. Subjects who have received a live vaccine within 4 weeks before the first dose of the study drug. Inactivated virus vaccines for seasonal influenza administered by injection are permitted, but live attenuated influenza vaccines administered nasally are not permitted;
7. Subjects with known history of allogeneic organ transplant or allogeneic stem cell transplant.
8. Subjects with known history of psychoactive drug abuse or drug addiction.
9. Pregnant or lactating women;
10. Subjects with diagnosis of any other malignant tumors within 5 years prior to study entry, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid cancer that have been locally treated and cured;
11. Subjects with other serious physical or mental illnesses or laboratory test abnormal findings that may increase the risk of study participation, or interfere with study results, and patients whom the investigator deems unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab and Cetuximab; Camrelizumab (Day 1) and Cetuximab Beta (Day 1, Day 8, Day 15), 2 cycles	Drug: Camrelizumab and Cetuximab; 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.
Active Comparator: Camrelizumab and Chemotherapy; Camrelizumab (Day 1), Paclitaxel Albumin - bound (Day 1, Day 8) and Carboplatin (Day 1), 2 cycles	Drug: Camrelizumab and Chemotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Yue He, MD

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: February 7, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab; Drug Therapy; camrelizumab
• Other Study ID Numbers: SH9H-2024-T339-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No