A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.

NCT Number	NCT07354984
Lead Sponsor	Sun Yat-sen University Collaborators: Biotech Pharmaceutical Co., Ltd., Lepu Biopharma Co., Ltd.
Conditions	Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Enrollment	30 participants
Start Date	2026-01-01
Primary Completion	2029-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-21