Abstract 21: Clinical Trials in Gastroesophageal Cancers: An Analysis of the Global Landscape of Interventional Trials From ClinicalTrials.gov

Abstract

Abstract Purpose: This study aims to describe the global landscape of clinical research into interventions for gastroesophageal (GE) cancers, which are a leading cause of cancer morbidity and mortality worldwide. We examine trial characteristics, focusing on geographic distribution of trial sites, participation of low-and-middle-income countries (LMICs), and factors associated with premature trial termination. Methods: We queried ClinicalTrials.gov database to identify all completed or terminated Phase III interventional studies investigating GE cancers (esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), gastroesophageal junctional (GEJ) and gastric adenocarcinoma). All reported characteristics were extracted. Pearson’s chi-square and Fisher’s exact test were used to compare differences in completed and terminated trials. Multivariate logistic regression was used to determine predictors of termination. Results: A total of 179 trials were identified; 90% were therapeutic. Most included sites in Asia (61%), Europe (32%), and North America (23%); few included sites in South America (9%), Africa (4%), and Oceania (9%). 63% of trials included high-income countries (HICs) sites alone; only 7% included sites in lower-middle or low-income countries. Most (70%) focused exclusively on gastric or GEJ adenocarcinoma, 13% on EAC and ESCC, and 9% ESCC alone. 16% (n=29) of trials terminated, most due to accrual difficulties (n=13, 44%). In multivariate analysis, study site number, location, and eligible patient population emerged as predictors of termination. Trials conducted exclusively in the US were more likely to terminate (OR 7.22 [95% CI 1.59-32.69]). Conversely, trials conducted exclusively in LMICs were less likely to terminate (OR 0.04 [95% CI 0.01-0.59] v conducted in HIC alone). Studies on ESCC were more likely to terminate (OR 17.74 [95%CI 1.49-210.69]). Trial design characteristics, intervention characteristics, and funding sources were not associated with termination. Conclusion: Although 80% of GE malignancies occur in LMICs, trial activity disproportionately occurs in HICs. Few trials focus on EAC/ESCC despite being highly fatal, highlighting an unmet need. Geographic location of trial sites emerged as a predictor of trial termination, with studies involving LMICs sites less likely to terminate prematurely. This finding highlights the potential benefit of including LMICs in future clinical trials to advance research for these diseases. Citation Format: Ayo Falade, Oluwatayo Adeoye, Geoffrey Buckle. Clinical Trials in Gastroesophageal Cancers: An Analysis of the Global Landscape of Interventional Trials From ClinicalTrials.gov [abstract]. In: Proceedings of the 11th Annual Symposium on Global Cancer Research; Closing the Research-to-Implementation Gap; 2023 Apr 4-6. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(6_Suppl):Abstract nr 21.