CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
NCT ID: NCT04481100
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
38 participants
INTERVENTIONAL
2020-10-01
2023-07-31
Brief Summary
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Detailed Description
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The aberrant activation of Hedgehog (HH) signaling is associated with a variety of human malignancies. Previous studies found that the reactivation of HH pathway occurs in 60% of esophageal cancer. Targeting the Hh pathway for cancer therapy was expected to work wonders in Hh-dependent cancers. Itraconazole, an antifungal agent, has been shown to inhibit the Hh and AKT signaling pathways.
The aim of our study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental Group
Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.
itraconazole
Oral administration of itraconazole twice daily concurrent with chemoradiation
Interventions
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itraconazole
Oral administration of itraconazole twice daily concurrent with chemoradiation
Eligibility Criteria
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Inclusion Criteria
Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.
Clinical staged T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa(AJCC 8th)
Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
ECOG 0-1.
Adequate organ function.
Patient has given written informed consent.
Exclusion Criteria
Known allergy to itraconazole
Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
Complete obstruction of the esophagus, or patients who have the potential to develop perforation, or unable to swallow Itraconazole.
Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
Pregnancy or breast-feeding.
Decision of unsuitableness by principal investigator or physician-in-charge.
18 Years
75 Years
ALL
No
Sponsors
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Hangzhou Cancer Hospital
OTHER
Responsible Party
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Shixiu Wu
Professor
Locations
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20200707
Identifier Type: -
Identifier Source: org_study_id
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