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NCT05563766
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Phase 2 trial testing Itraconazole in Esophageal Adenocarcinoma in 78 participants. Currently enrolling.
30 April 2029
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 1 October 2024 |
| Primary completion | 30 April 2029 |
| Estimated completion | 15 June 2029 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Itraconazole — full drug profile →
Conditions studied
- Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
- Gastroesophageal Junction Carcinoma — all drugs for Gastroesophageal Junction Carcinoma →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
18 and older, any sex, with Esophageal Adenocarcinoma or Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709 -
Emerging Roles of Using Small Extracellular Vesicles as an Anti-Cancer Drug.
Joo HS, Suh JH, So CM, Jeon HJ, et al · · 2023 · cited 6× · PMID 37762393 · DOI 10.3390/ijms241814063 -
The Interplay Between Esophageal Adenocarcinoma and Its Tumor Microenvironment: Toward Innovative Therapies.
Fioretzaki R, Trifylli EM, Sarantis P, Charalampakis N, et al · · 2025 · PMID 41369383 · DOI 10.3390/cells14231895
Verify or expand the search:
- PubMed search for NCT05563766
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Itraconazole
Trials testing the same drug.
- NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
- NCT06732388 — Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's E · Phase 2 · not yet recruiting
- NCT07449390 — Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole · Phase 1 · not yet recruiting
- NCT07435194 — A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazo · Phase 1 · recruiting
- NCT07308652 — A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood · Phase 1 · completed
Other recruiting trials for Esophageal Adenocarcinoma
Currently open trials in the same condition.
- NCT07392892 — A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer · Phase 2, PHASE3 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT07182149 — A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors · Phase 1 · recruiting
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07021066 — Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors · Phase 1 · recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
- NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
- NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05563766 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 5 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05563766.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing