Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC

This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.

NCT Number	NCT06935188
Lead Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions	Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Enrollment	98 participants
Start Date	2025-04-17
Primary Completion	2028-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-18