Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients

Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients

This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).

Inclusion Criteria:

• Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck;
• Resectable or potentially resectable lesion;
• ECOG PS 0-1;
• Age >18 years old;
• At least one target lesion according to RECIST 1.1;
• Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery;

Exclusion Criteria:

• Distant metastasis;
• Second malignancy within 5 years;
• Nasopharyngeal carcinoma;
• Active autoimmune diseases;
• HIV infected;
• Required prednisone dose >=10mg daily;
• Heart attack within 6 months;
• Stroke within 6 months;
• Other conditions that investigators consider the patients are not suitable for PD-1antibody;