Head and neck squamous cell carcinoma
Conditions
Interventions
Surgery group:Neoadjuvant immunotherapy combined with chemotherapy followed by surgery treatment
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years, both males and females are eligible. 2. ECOG performance status of 0-2 (see Appendix 1). 3. Histopathologically confirmed squamous cell carcinoma of the head and neck region (including tumors originating from the oral cavity, larynx, hypopharynx, or cervical esophagus). 4. Surgically resectable, with pathological staging of III/IV, local T2-4N1-3M0. 5. No prior treatment, including radiotherapy, chemotherapy, immunotherapy, or biological therapy, or any other anti-cancer treatment. 6. At least one measurable lesion (according to RECIST 1.1 criteria, see Appendix 2). 7. Life expectancy of not less than 6 months. 8. No contraindications to chemotherapy or immunotherapy. 9. The function of important organs must meet the following requirements (no use of any blood components, growth factors, white blood cell-stimulating drugs, platelet-stimulating drugs, or anemia-correcting drugs within 14 days before the first use of the study medication): A. WBC >= 3.0 x 10^9 /L, ANC >= 2.0 x 10^9/L B. Hemoglobin >= 90g/L C. Platelets >= 100 x 10^9 /L D. Serum albumin >= 2.8g/dL E. Total bilirubin 60mL/min G. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5x ULN (patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range of the anticoagulant may be screened) 10. Female subjects of childbearing potential, and male subjects whose partners are of childbearing age, must use a medically recognized contraceptive method (such as intrauterine devices, contraceptive pills, or condoms) during the study treatment, and for at least 3 months after the last use of toripalimab and at least 6 months after the last use of chemotherapy or radiotherapy. 11. The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patient age is less than 18 or greater than 65 years old. 2. Histopathological types of head and neck tumors other than squamous cell carcinoma. 3. Evidence of distant metastasis. 4. History of other malignancies at other sites (except for malignancies that have been cured and have been cancer-free for more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, and papillary thyroid carcinoma, etc.). 5. Patients with a history of allergy to any component of monoclonal antibody drugs or those with a constitutional allergy. 6. Uncontrolled clinical symptoms or diseases of the heart, such as: NYHA class II or higher heart failure or echocardiography indicating a left ventricular ejection fraction (LVEF) of less than 50%; unstable angina; myocardial infarction within the past year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval >=470 ms). 7. Serious infections (CTC AE > grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggesting active pulmonary inflammation, presence of symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or requiring oral or intravenous antibiotic treatment (excluding the use of antibiotics for prophylaxis). 8. Unexplained fever >38.5°C during the screening period or before the first dose (patients judged by the investigator to have tumor fever may be included). 9. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but does not include hypothyroidism mediated by autoimmune diseases treated with a stable dose of thyroid hormone replacement; type I diabetes mellitus treated with a stable dose of insulin; vitiligo or childhood asthma/allergies that have healed and do not require any intervention in adulthood. 10. History of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation. 11. Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA >2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA > 103 copies/mL; patients who are positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibodies. 12. History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids), non-infectious pneumonia. 13. Active tuberculosis infection found by history or CT scan, or patients with a history of active tuberculosis infection within the last year, or patients with a history of active tuberculosis infection more than a year ago but not treated properly. 14. Patients who have received any of the following treatments: A. Any investigational drugs within 4 weeks before the first use of the study drug. B. The last dose of anticancer treatment (including chemotherapy, radiotherapy, targeted therapy, etc.) within <=4 weeks before the first use of the study drug. C. Subjects requiring systemic treatment with corticosteroids (more than 10 mg/day equivalent dose of prednisone, etc.) or other immunosuppressants within 2 weeks before the firs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR (major pathological response); | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate (pathological complete response);Treatment related adverse events (TRAE);Overall survival(OS);Objective Response Rate (ORR);progression-free survival(PFS); | — |
Countries
China
Contacts
Public ContactChangming An
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed