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Itraconazole with Ablation for High-Risk Barrett's Esophagus

This study is looking at whether itraconazole, a medication typically used for fungal infections, can help prevent esophageal cancer in people with high-risk Barrett's esophagus (a condition where the lining of your esophagus changes). You might be able to join if you are 18 or older, have a diagnosis of Barrett's esophagus that is at least 2 cm long with certain cell changes (low-grade or high-grade dysplasia) or early-stage esophageal cancer, and are being considered for ablation (a procedure to remove abnormal tissue). The study aims to see if itraconazole, when combined with standard ablation treatment, can help your esophagus return to normal faster. The study is also looking at how safe itraconazole is and how well your body tolerates it.

Study design
This study plans to enroll 76 participants and will randomly assign them to one of two groups. One group will receive itraconazole, and the other will receive a placebo (an inactive substance).
What's involved
You would undergo tissue biopsies, blood sample collections, and endoscopy procedures. If in the itraconazole group, you would take itraconazole by mouth twice daily for 42 days per cycle.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the time until your esophagus returns to normal, which is assessed between day 1 of the first cycle (a cycle is 6 weeks) and the date of an endoscopy showing this change.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06732388

Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus

Recruiting
PHASE2Ages 18+InterventionalPrevention
National Cancer Institute (NCI)
~76 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionEndoscopic ProcedureItraconazolePlacebo AdministrationQuestionnaire Administration

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to complete eradication of intestinal metaplasia (CEIM) in days
Measured over Between day 1, cycle 1 (1 cycle = 6 weeks) and the date of endoscopy at which the participant is deemed to reach CEIM

Conditions

Barrett Esophagus
Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
Esophageal Adenocarcinoma

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Barrett EsophagusEsophageal Adenocarcinoma

NCT06732388

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor University Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohiostudy coordinator listed

    Not yet recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansasstudy coordinator listed

    Not yet recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ajay Bansal, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

David Wang
[email protected]
734-232-4594
Email the study team

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Eligibility criteria

Inclusion

Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), naïve to treatment, and being considered for ablation.
Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the referring site and an institutional pathologist at the local enrolling site, two pathologists from the referring site, or two pathologists from the local enrolling site. The diagnosis between two pathologists has to be concordant regarding the presence of dysplasia or cancer. Discrepant diagnoses will be resolved by a third pathologist, if needed
Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \< 18 years of age, children are excluded from this study
Clinically eligible for EGD and endoscopic treatment of BE
Absolute neutrophil count ≥ 1,000/microliter
Platelets ≥ 100,000/microliter
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
Note: Higher total bilirubin levels (≤ 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 1.5 × institutional upper limit of normal
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing potential must agree to use one or more methods of highly effective contraception that do not contain estrogen (e.g. progestin only oral contraceptive, non-hormonal intrauterine device, bilateral tubal ligation) two months prior to study entry, for the duration of study participation and two months after completing the study drug. Women should not donate eggs or participate in in vitro fertilization for the duration of study participation, and two months after completing the study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Male subjects should avoid donating sperm, and if engaged in intercourse with women of child-bearing potential use a method of highly effective contraception.
Activities of Reproductive Potential: In addition to heterosexual intercourse, activities that could lead to pregnancy (e.g. sperm or egg donation, participation in in vitro fertilization) should be considered when evaluating the reproductive potential of clinical trial subjects.
Females of Reproductive Potential: A non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure. A female who has had a tubal ligation sterilization, or hysterectomy would not be considered to be of reproductive potential unless participating in activities of reproductive potential other than heterosexual intercourse (e.g. egg donation, participation in in vitro fertilization).
Menopause:
Twelve (12) months of spontaneous amenorrhea or;
Spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/mL or;
Subject is post-bilateral oophorectomy with or without hysterectomy
Ability to understand and the willingness to sign a written informed consent document

Exclusion

Current New York Heart Association (NYHA) class III or IV congestive heart failure
Prolonged corrected QT (QTc) (\> 450 ms for men and \> 470 ms for women)
Participants may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole
Uncontrolled intercurrent illness., or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with itraconazole, breastfeeding should be discontinued if the mother is treated with itraconazole
Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a case-by-case basis by the site investigators in consultation with the treating provider. Drug interactions can be assessed using one of the available on-line resources, for instance, UpToDate or Clinical Formulary and/or in collaboration with a clinical pharmacist.
Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management will be required before the participants are enrolled in the trial
History of eosinophilic esophagitis
History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly
Participants must not have evidence of active/recurrent invasive cancer of a non-esophageal organ
Participants with EAC greater than stage T1a
Persistent (\> 24 hour \[h\]) systolic blood pressure (BP) greater than or equal to 160 mmHg (to avoid reaching hypertensive crisis defined as systolic BP \> 180 mmHg)
Patients taking eliglustat. Co-administration of itraconazole and eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6

What this trial measures

  • Time to complete eradication of intestinal metaplasia (CEIM) in daysBetween day 1, cycle 1 (1 cycle = 6 weeks) and the date of endoscopy at which the participant is deemed to reach CEIM

    CEIM will be defined based on the absence of visible Barrett's esophagus (BE) and invisible BE (i.e., no intestinal metaplasia \[IM\] in biopsies of the gastroesophageal junction and the cardia). Will be reported descriptively. Will compare the unadjusted hazard rates between the itraconazole and control groups using log rank test.