The Current Landscape of Oral Squamous Cell Carcinoma: A Comprehensive Analysis from ClinicalTrials.gov

OBJECTIVE: A better understanding of the current characteristics of clinical trials in oral squamous cell carcinoma (OSCC) is important to improve trial design and identify neglected areas of research. The objective is to summarize the current characteristics and publication status of OSCC trials registered on ClinicalTrials.gov. METHODS: The ClinicalTrials.gov database was searched on November 9, 2020, for trials containing the term “oral squamous cell carcinoma”. We assessed the characteristics of the included trials and searched the publication status of the primary completed trials by using PubMed and Google Scholar. RESULTS: Our search identified 325 studies for analysis, including 279 interventional (85.8%) and 46 observational (14.2%) studies. Interventional studies were mostly single-group (50.9%), single-center (57.0%), non-randomized (59.1%), open-label (81.4%), and early-phase (70.6%) trials. The vast majority of the studies (82.8%) focused on the treatment of OSCC. Chemotherapy (36.8%) was the most common treatment, followed by targeted therapy (15.2%) and immunotherapy (15.2%). Furthermore, 58.9% of the primary completed interventional studies were published by January 8, 2021, and the median time to publication was 48.0 months. Studies registered before this study began (HR = 1.69, 95% CI = 1.02–2.80, P = .040) and in phases 1/2 or 2 (HR = 2.10, 95% CI = 1.09–4.06, P = .026) were associated with an improved likelihood of publication. CONCLUSIONS: OSCC clinical trials usually have small sample size and are open-label and non-randomized studies. Advanced OSCC and immunotherapy-oriented therapy are becoming the focus of current trials. Researchers should perform standardized registration and publish their results in a timely manner.