The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC

All participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.

Inclusion criteria

• Males and females ≥18 years of age.
• ECOG Performance Status 0 or 1.
• Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
• Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
• Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
• With measurable target lesions by CT or MRI.
• Adequate bone marrow function.
• Adequate renal and liver function.
• Pregnancy test (for patients of childbearing potential) negative at screening.
• Signed Written Informed Consent.

Exclusion criteria

• Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
• Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
• Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
• Pregnancy or breast feeding.
• Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
• Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
• Has received a live vaccine within 4 weeks of planned start of study therapy.
• Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.