A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.
• 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.