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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 (May 2026). This Phase 2 trial studies Itraconazole for esophageal adenocarcinoma.

Phase 2RecruitingVA Office of Research and DevelopmentNCT05563766Data as of May 2026

Treatment: ItraconazoleEsophageal 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.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Gastric Cancer

Performance status

WHO/ECOG 0–2

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

NYHA class III or IV CHF [excluded]; QTc>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant

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 during therapy by serial EKG

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 →

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