5-fluorouracil

P2, N=20, Not yet recruiting, Washington University School of Medicine | Trial completion date: Apr 2030 --> Jul 2030 | Initiation date: Oct 2025 --> Jan 2026 | Trial primary completion date: Apr 2030 --> Jul 2030

P4, N=2, Terminated, Ottawa Hospital Research Institute | Completed --> Terminated; The study did not meet the pilot feasibility endpoints and was formally closed to accrual prematurely on February 8, 2017.

Therapeutic combination index analysis indicated robust synergy between FMNT and 5-FU, with combination therapy achieving superior tumor growth inhibition compared to monotherapies. Collectively, our findings uncover a novel miR-490-3p/ABCC2 regulatory mechanism underlying FMNT's antitumor activity and highlight its potential for chemosensitization through ABCC2 inhibition, providing a strong rationale for flavonoid-based adjuvant therapy in CRC management.

P2, N=38, Suspended, Rutgers, The State University of New Jersey | Trial completion date: Jan 2026 --> Jan 2028 | Recruiting --> Suspended | Trial primary completion date: Jan 2026 --> Dec 2027

Observational studies have associated use of aspirin and selective cyclooxygenase inhibitors with decreased recurrence and improved survival in patients with colon cancer...This was a post hoc analysis of the phase 3 Cancer and Leukemia Group B (now Alliance)/Southwest Oncology Group 80702 randomized clinical trial (2010-2015) assessing adjuvant celecoxib vs placebo and 3 vs 6 months of adjuvant 5-fluorouracil, leucovorin, and oxaliplatin for stage III colon cancer...The findings of this post hoc analysis suggest that ctDNA status has the potential to inform clinical decision-making among patients with stage III colon cancer who should consider adjuvant celecoxib in addition to conventional chemotherapy. ClinicalTrials.gov Identifier: NCT01150045.

Preclinical studies demonstrate that MEL enhances chemoradiotherapy efficacy-reducing tumor volume by 70% in murine colorectal models and decreasing 5-fluorouracil (5-FU) resistance via miR-532-3p/β-catenin axis modulation...Given its low toxicity and putative synergy with immunotherapies, MEL should be regarded as an adjunct under investigation rather than an established option; to date, no GI-specific phase III randomized trials exist, and clinical signals come primarily from small, heterogeneous cohorts. Dosing is unstandardized and limited by low oral bioavailability (first-pass) and possible pharmacogenomic variability.

ROC curve analysis showed that the AUCs for predicting myocardial injury in the training and validation sets were 0.901 (95% CI: 0.823-0.978) and 0.879 (95% CI: 0.819-0.938), respectively, with sensitivities and specificities of 0.756, 1.000 and 0.703, 0.951, respectively. This predictive model aids in the early identification of myocardial injury, guiding clinical decision-making and improving prognosis.

P3, N=262, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | N=192 --> 262 | Trial completion date: Jul 2027 --> Jul 2029 | Trial primary completion date: Jul 2026 --> Jul 2028

P3, N=89, Completed, Incyte Corporation | Active, not recruiting --> Completed

DPYD rs4294451 T-allele count and male sex were significantly associated with reduced 5-FU drug exposure. DPYD rs4294451 and male sex merit further evaluation as candidate biomarkers to inform initial dosing of infusional 5-FU.

The discovery of rare DPYD variants followed by functional characterization may aid in further optimization of fluoropyrimidine dosing.

P3, N=320, Not yet recruiting, Genfleet Therapeutics (Shanghai) Inc.