Characteristic of Immunotherapy Trials in Head and Neck Squamous Cell Carcinoma: 2013-2023.

Objective: This research provides a comprehensive analysis of immunotherapy clinical trials for head and neck squamous cell carcinoma, aiming to enhance future trial designs.

Methods: We analyzed all clinical trials focused on head and neck squamous cell carcinoma immunotherapy registered on ClinicalTrials.gov from January 1st, 2013, to December 31st, 2023, examining general characteristics, methodological features, and types of immunotherapeutic drugs.

Results: The analysis included 727 trials, with 687 interventional (94.50%) and 40 observational (5.50%). Most trials were small-sized (64.37%), single-centered (56.67%), non-blinded (94.76%), and non-randomized (72.93%). Over half of the trials were conducted in North America (55.71%), but trials in Asia increased significantly in the past 5 years (9.88% vs. 32.38%, p < 0.001). Only 20.63% of completed trials updated outcomes, with most results published 6-12 months after primary completion (55.13%). Immune checkpoint inhibitors were the predominant focus, and neoadjuvant immunotherapy was the main regimen in trials with resectable head and neck squamous cell carcinoma (74.83%).

Conclusions: There has been a gradual increase in clinical trials over the past decade, with most being interventional. Delays or absences in outcome submission were prevalent. Novel immunotherapeutic drugs and treatment regimens are a significant focus.