Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
experimental group:neoadjuvant radiation and anti-PD-1 antibody treatment
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, gender is not limited; 2. Pathologically confirmed SCCHN, not previously treated; 3. Patients who have stage III-IV disease without distant metastases of 1) oral cavity, 2) larynx, 3) hypopharynx 4) oropharynx using American Joint Committee on Cancer (AJCC) 8th edition; 4. Patients must be evaluated by a head and neck surgeon and be deemed surgically resectable at baseline; 5. Patients Must be willing to undergo definitive resection with neck dissection; 6. All patients with oropharyngeal SCCHN must be tested for HPV (by p16 and/or HPV in situ hybridization [ISH] or polymerase chain reaction [PCR]); 7. According to RECIST version 1.1 standard, there is at least one target lesion that can be evaluated; 8. The physical condition of ECOG was 0-1; 9. The function of the main organs is normal, which meets the following criteria: (1) Blood routine examination standards should be met: (no blood transfusion within 14 days) A. Hb > 90g/L: B. ANC (> 1.5x10^9/L); C. PLT (> 80x10^9/L); (2) Biochemical tests should meet the following criteria: A. BIL 50ml/min (Cockcroft-Gaut formula); 10. Sign a written informed consent before conducting any test-related activities; 11. Researchers judged that they could follow the research plan; 12. Pregnancy tests at screening (for women with fertility) were negative; 13. Fertile men and women at risk of fertility and pregnancy must agree to use two contraceptive methods throughout the study period (at least one of which is considered to be an efficient method of contraception); Female patients without fertility (i.e. meeting at least one of the following criteria): - Has undergone hysterectomy and/or bilateral ovariectomy, and has been documented; - Medically confirmed ovarian dysfunction; Postmenopausal status is defined as menopause for at least 12 consecutive months without any other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status. 14. A signed and dated informed consent indicates that the patient (or legal representative, if permitted by the local guidelines/practice guidelines) has been informed of all relevant aspects of the study. 15. Patients willing and able to comply with visiting arrangements, treatment plans, laboratory tests and other research procedures.
Exclusion criteria
Exclusion criteria: 1. Primary nasopharyngeal carcinoma; 2. Patients with metastatic SCCA neck disease with an unknown primary tumor site; 3. Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies (including aspirin monoclonal antibody) or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathway; 4. Major operations less than 4 weeks before admission; 5. Allergies to PD-1 antibody or its excipients have been confirmed; 6. Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy is effective): vitiligo or childhood asthma Complete remission, adult asthma patients without any intervention and need bronchodilator for medical intervention can be included; 7. Past or concurrent malignant tumors (except those that have been cured and have survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma); 8. Uncontrolled cardiac symptoms or diseases, such as: (1) heart failure above NYHA II level; (2) unstable striatal pain; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 9. Within 14 days before giving the study drug, subjects requiring systemic treatment with corticosteroids (>10mg/prednisone therapeutic dose) or other immunosuppressive agents were allowed to inhale or locally administer steroids or an adrenal dose of prednisone therapeutic dose > 10mg/day in the absence of active autoimmune diseases. Hormone replacement; 10. Active infections requiring treatment; 11. Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA (> 104 (copy number/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method); 12. Patients have received other treatments before consulting; 13. Begin the study of vaccination with live vaccine within 4 weeks before treatment; 14. Known history of psychotropic drug abuse, alcoholism or drug abuse; 15. Pregnant or lactating women; 16. According to the judgement of the researchers, there are other factors that may lead to the forced termination of the study, such as the need for combined treatment for other serious diseases (including mental disorders), severe abnormal laboratory values, family or social factors, which may affect the safety of the subjects or the collection of experimental data. 17. Active pulmonary tuberculosis; 18. Begin research on severe infections within 4 weeks of treatment (including but not limited to hospitalization due to infections, bacteremia or complications of severe pneumonia); 19. Systemic immunostimulatory drugs (including but not limited to interferon or interleukin-2 (IL-2) were administered within 4 weeks before the start of the study, or were still in the half-life of five drugs (the longer of the two). 20. Ineligible subjects considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-y DFS;2-y OS; | — |
Countries
China
Contacts
Public ContactHe Yue
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed