Abstract
<title>Abstract</title> <p> <bold>Objective</bold> China records approximately 130,000 new head and neck cancer (HNC) cases annually, representing 3%-6% of all malignant neoplasms nationwide. This study sought to systematically characterize the landscape of HNC clinical trials conducted in China over the past decade, identifying both strengths and deficiencies in the current research and development (R&D) ecosystem, with the goal of informing future drug development strategies for HNC. <bold>Methods</bold> We retrieved comprehensive data on HNC clinical trials from the National Medical Products Administration (NMPA) Clinical Trial Registration and Information Disclosure Platform (http://www.chinadrugtrials.org.cn) covering the period from September 6, 2013 to December 31, 2025. The analysis encompassed trial characteristics, drug mechanisms, data safety monitoring, participant protection, geographical distribution of leading institutions, and trial scale. <bold>Results</bold> A total of 160 registered HNC drug clinical trials were identified, of which 88 (54.7%) were actively ongoing, 42 (26.1%) had been completed, and 30 (18.8%) were either suspended or terminated. Phase II trials constituted the largest proportion. Non-randomization, single-arm, open-label designs predominated, and the vast majority (157 trials, 98.1%) imposed no gender-based restrictions. Biologics represented the most common drug category (71.4%, n=115), while no traditional Chinese medicine or natural product trials were registered. Targeted therapies accounted for the highest proportion (75.6%, n=121), followed by cytotoxic agents (11.9%, n=19) and immunotherapies (6.2%, n=10). Domestic sponsors were responsible for the majority of trials (82.5%, n=132). Leading institutions were predominantly situated in eastern China (48.8%, n=78). Only 18.1% (n=29) of trials had established a data monitoring safety committee, whereas 87.5% (n=140) had procured clinical trial insurance for participants. <bold>Conclusion</bold> Over the past 13 years, the clinical trial enterprise for HNC in mainland China has advanced considerably. Nevertheless, future endeavors should prioritize novel target discovery, enhanced utilization of traditional Chinese medicine and natural medicine resources, strengthened research capacity within stomatology hospitals, and sustained commitment to pharmaceutical innovation. </p>