OncoMatch/Clinical Trials/NCT05563766
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Is NCT05563766 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Itraconazole for esophageal adenocarcinoma.
Treatment: Itraconazole — 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 or chemoimmunotherapy and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Gastric Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 at enrollment
Lab requirements
Kidney function
Adequate renal function as judged by the treating physician
Liver function
Adequate liver function as judged by the treating physician; LFT>3X upper limit of normal [excluded]
Cardiac function
New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) [excluded]; QTc>450 ms will have QTc monitored during therapy by serial EKG
Adequate renal and liver function as judged by the treating physician; NYHA class III or IV CHF [excluded]; LFT>3X upper limit of normal [excluded]; QTc>450 ms will have QTc monitored
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- VA Palo Alto Health Care System, Palo Alto, CA · Palo Alto, California
- VA Ann Arbor Healthcare System, Ann Arbor, MI · Ann Arbor, Michigan
- Durham VA Medical Center, Durham, NC · Durham, North Carolina
- VA Portland Health Care System, Portland, OR · Portland, Oregon
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05563766 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages