Head and Neck Squamous Cell CarcinomaPhase 3NCT07432087
Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing Camrelizumab and Cetuximab and Camrelizumab and Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Yue He, MD.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Camrelizumab and Cetuximab and Camrelizumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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:
- 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);
- 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);
- 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;
- 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.
Who cannot join
- 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;
- 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);
- 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);
- Subjects with known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.
- 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.
- 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;
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- Subjects with known history of allogeneic organ transplant or allogeneic stem cell transplant.
- Subjects with known history of psychoactive drug abuse or drug addiction.
- Pregnant or lactating women;
- 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;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Camrelizumab and Cetuximab, Camrelizumab and Chemotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab and CetuximabDrug
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 and ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab and Cetuximab | Experimental | Camrelizumab (Day 1) and Cetuximab Beta (Day 1, Day 8, Day 15), 2 cycles Receives: Drug: Camrelizumab and Cetuximab |
| Camrelizumab and Chemotherapy | Active comparator | Camrelizumab (Day 1), Paclitaxel Albumin - bound (Day 1, Day 8) and Carboplatin (Day 1), 2 cycles Receives: Drug: Camrelizumab and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years from the date of randomization
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yue He, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yue He, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432087
- Sponsor's protocol ID
- SH9H-2024-T339-3
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07432087
- Acronym / sponsor ID
- SH9H-2024-T339-3
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Yue He, MDUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab and Cetuximab | Experimental | Drug: Camrelizumab and CetuximabCamrelizumab (Day 1) and Cetuximab Beta (Day 1, Day 8, Day 15), 2 cycles |
| Camrelizumab and Chemotherapy | Active comparator | Drug: Camrelizumab and ChemotherapyCamrelizumab (Day 1), Paclitaxel Albumin - bound (Day 1, Day 8) and Carboplatin (Day 1), 2 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
- 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);
- 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);
- Subjects with known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab and CetuximabCamrelizumab 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. | Drug | Camrelizumab and Cetuximab |
| Camrelizumab and ChemotherapyCamrelizumab 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. | Drug | Camrelizumab and Chemotherapy |
Primary outcome
2-year Overall Survival (OS) Rate
Time frame: 2 years from the date of randomization
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).
9 secondary outcomes
2-year Event-Free Survival (EFS) Rate
Time frame: 2 years from the date of randomization
Pathologic Complete Response (pCR) Rate
Time frame: Within 1 month after surgery
Major Pathologic Response (MPR) Rate
Time frame: Within 1 month after surgery
Objective Response Rate (ORR) assessed by RECIST 1.1
Time frame: Perioperative
3-year and 5-year Event-free Survival (EFS) Rates
Time frame: 3 years and 5 years from the start of randomization
3-year and 5-year Overall Survival (OS) Rates
Time frame: 3 years and 5 years from the start of randomization.
Quality of Life (QoL) Assessment by EORTC QLQ-C30
Time frame: Perioperative
Quality of Life (QoL) Assessment by H&N35
Time frame: Perioperative
Adverse Events (AEs)
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camrelizumab and Cetuximab and Camrelizumab and Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Yue He, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue He, M.D. (+86-021-23271699-5154, william5218@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Overall Survival (OS) Rate (time frame: 2 years from the date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.