Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

Cannot have received: systemic therapy for advanced (metastatic) or unresectable (locally advanced) tonsillar cancer

Exception: neoadjuvant/adjuvant therapy completed at least 6 months before diagnosis of advanced and/or unresectable disease; subjects with R2 pathology after tumor resection are excluded

Prior systemic therapy for advanced (metastatic) or unresectable (locally advanced) tonsillar cancer, except for permitted neoadjuvant/adjuvant therapy. Neoadjuvant/adjuvant therapy must have been completed at least 6 months before the diagnosis of advanced and/or unresectable disease. Subjects who received prior neoadjuvant/adjuvant therapy and had R2 pathology after tumor resection are excluded.

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy

Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137)

Cannot have received: EGFR-targeted therapy

Prior treatment with EGFR-targeted agents

Cannot have received: anti-tumor therapy for advanced tonsillar cancer, including investigational drugs

Exception: within 4 weeks before enrollment

Anti-tumor therapy for advanced tonsillar cancer, including investigational drugs, within 4 weeks before enrollment

Cannot have received: radiotherapy

Exception: within 2 weeks before the start of investigational treatment; 1-week washout for palliative radiotherapy (≤2 weeks) for non-CNS disease; 2-week washout for longer radiotherapy courses (>2 weeks)

Radiotherapy within 2 weeks before the start of investigational treatment. Subjects must have recovered from all radiotherapy-related toxicities, be free of corticosteroid use, and have no history of radiation pneumonitis. A 1-week washout period is permitted for palliative radiotherapy (≤2 weeks of radiotherapy) for non-central nervous system (CNS) disease (if deemed safe by the investigator). A 2-week washout period is required for longer radiotherapy courses (>2 weeks).