Squamous cell carcinoma of head and neck
Conditions
Interventions
carrellizumab group:carrellizumab combination with concurrent chemoradiotherapy and adjuvant carrellizumab
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced squamous cell carcinoma of the head and neck (oral, oropharyngeal, hypopharyngeal, laryngeal) confirmed by pathology or histology, except nasopharyngeal, with at least one possible lesion (>=10mm on MRI or spiral CT, RECISTI. 1); 2. ECOG score 0-1; 3. Normal function of major organs, that is, blood routine and biochemical tests meet standards; 4. Subjects were aged 18-05 at the time of signing the informed consent and were enrolled in this study voluntarily; 5. Sufficient tissue samples are available for PP-LI testing or exploratory analysis.
Exclusion criteria
Exclusion criteria: 1. The pathology was indeed non-squamous cell carcinoma; 2. Patients with recurrence and distant metastasis; 3. Surgical intervention was the first treatment, except for diagnostic biopsy of primary site and regional lymph nodes; 4. Prior chemotherapy for any reason, or radiation therapy for the head and neck area, or molecular-targeted drug therapy; Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or other drugs acting on another stimulating or co-inhibitory T cell receptor (such as CTLA-4, OX 40, CD137) or cell biotherapy; 5. Pregnant or lactating women; 6. Previous or concurrent malignancy; 7. The patient suffers from other uncontrolled serious diseases; 8. Abnormal functions of heart, brain, lung and other important organs; 9. Glucocorticoid treatment 30 days before first administration (> 10mg prednisone equivalent dose per day); 10. Has an active autoimmune disease requiring systemic therapy (i.e., disease-regulating drugs, corticosteroids, or immunosuppressive drugs) in the past 2 years; 11. Active infections such as tuberculosis requiring systemic treatment; 12. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 13. Untreated active hepatitis B; 14. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders; 15. The investigator determines other conditions that may affect the conduct of the clinical study and the determination of the study results; 16. Participate in another therapeutic clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;overall survival (OS);Local control rate;distant metastasis-free survival (DMFS); | — |
Countries
China
Contacts
Public ContactLiuFeng
Hunan Cancer Hospital
Outcome results
None listed