Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Nimotuzumab combined with toriipalimab and chemotherapy
control group:Chemotherapy
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed locally advanced head and neck squamous cell carcinoma (stage III-IVb oral cancer, hypopharyngeal cancer, laryngeal cancer and HPV-negative oropharyngeal cancer: T3-4N0M0/T1-4N1-3M0; stage II-III HPV-positive oropharyngeal cancer: T3-4N0-3M0/T0-2N2-3M0) (according to the ninth edition of AJCC clinical staging criteria) (note: patients should receive enhanced magnetic resonance imaging (MRI) of the primary site and neck of the tumor for staging before treatment; if patients have contraindications to MRI, enhanced computed tomography (CT) examination can also be accepted.Examinations to exclude distant metastasis included chest X-ray, liver ultrasound and whole-body bone imaging, and enhanced CT/MRI or PET/CT could also be used); 2. Patients who are unsuitable for surgery (defined as patients unable to undergo surgery due to physical condition or medical reasons, or tumors that cannot achieve R0 resection) 3. Age: 18–75 years with no severe dysfunction of major organs, such as the heart, lungs, liver, or kidneys. 4. ECOG performance status (PS) score of 0 or 1. 5. No prior radiotherapy to the head and neck region prior to enrollment. 6. Laboratory parameters: - White blood cell count >3.0×10^9/L - Neutrophil count >1.5×10^9/L - Platelet count >100×10^9/L - Hemoglobin >90g/L - Serum total bilirubin = 60mL/min Coagulation parameters: APTT prolongation not exceeding 10 seconds and PT prolongation not exceeding three seconds from the upper limit of normal. 7. Female participants must have a negative pregnancy test result within two weeks prior to initiating the study medication. They must also agree to not breastfeed and to use effective contraception during the study period and for six months after the last administration of the study drug. Male participants must also agree to use effective contraception during the study period and for six months after the last administration of the study drug. 8. Participants must voluntarily enroll in the study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or reproductive-age participants unwilling or unable to use effective contraceptive measures until at least six months after the last trial treatment (applicable to both male and female participants). 2. Participants with a history of allergy to any component of the large-molecule protein preparation used in this protocol or to any component of toripalimab are not eligible. 3. Participants with central nervous system metastases with clinical symptoms, including brain edema requiring hormonal intervention or progression of brain metastases are not eligible. 4. History of other malignant tumors within the past five years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma. 5. Prior treatment with any of the following: a. Receipt of PD-1/PD-L1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within the past four weeks b. Participation in any investigational drug trials within four weeks prior to the first administration of the study drug c. Concurrent enrollment in another clinical trial unless it is observational (non-interventional) or for follow-up after an interventional trial; d. Receipt of systemic corticosteroids at an equivalent dose of more than 10 mg of prednisone per day or other immunosuppressive therapy within 28 days before signing the informed consent form; e. Receipt of an antitumor vaccine or live vaccine within 28 days before signing the informed consent form; f. Undergone major surgery or severe trauma within 28 days before the first use of the study drug. Participants receiving systemic corticosteroids at a dose of <= 10 mg of prednisone per day or inhaled/topical corticosteroids may be eligible. E. Received an antitumor vaccine or a live vaccine within four weeks prior to the first administration of the study drug. F. Undergone major surgery or severe trauma within four weeks prior to the first use of the study drug. 6. Uncontrolled cardiac symptoms or diseases such as: (1) New York Heart Association (NYHA) Class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, or (4) clinically significant supraventricular or ventricular arrhythmias requiring intervention. 7. Severe infection (CTCAE Grade 2 or higher) within four weeks prior to the first use of the study drug. This includes severe pneumonia requiring hospitalization, bacteremia, or infection-related complications. It also includes baseline chest imaging studies indicating active pulmonary inflammation. It includes symptoms or signs of infection within two weeks prior to the first use of the study drug. It includes requiring oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use). 8. History of interstitial lung disease or non-infectious pneumonia. 9. Patients with active tuberculosis identified through medical history or CT examination. This includes patients with a history of active tuberculosis within one year prior to enrollment and patients with a history of active tuberculosis more than one year prior who have not received standard treatment. 10: Active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones; type 1 diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response;Quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year Distant Metastasis Free Survival ;2-year Locoregional Relapse-free Survival;Objective Response Rate,ORR;2-year Progression-free Survival;2-year Overall Survival; | — |
Countries
China
Contacts
Public ContactGuoyi Zhang
The First People's Hospital of Foshan
Outcome results
None listed