CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    38
  • sponsor
    Hangzhou Cancer Hospital
Updated on 26 January 2021
cancer
measurable disease
carcinoma
squamous cell carcinoma
chemoradiotherapy
esophageal cancer
esophageal carcinoma
solid tumors
esophagus cancer
esophageal squamous cell carcinoma
squamous cell carcinoma of esophagus

Summary

The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer

Description

Esophageal cancer is one of the most lethal malignancies. Esophageal squamous cell carcinoma (ESCC) is the predominant type in China, accounting for over 90% of all esophageal cancer. Concurrent chemoradiation therapy (CCRT) remains the standard therapy of locally advanced ESCC. However, the outcome remains poor.

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

Details
Condition Esophageal Diseases, Esophageal Disorders, Esophageal Cancer, Esophageal Cancer, Squamous cell carcinoma, Squamous cell carcinoma, GASTROINTESTINAL DISORDER, Gastrointestinal Diseases and Disorders, head and neck cancer, head and neck cancer, Gastrointestinal Diseases and Disorders, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Esophagus, Esophageal Disorders
Treatment Itraconazole
Clinical Study IdentifierNCT04481100
SponsorHangzhou Cancer Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

age:18-75 years, male or femal
Histologically or cytologically confirmed Squamous Cell Carcinoma of the
Esophagus, locally advanced, unresectable disease
Clinical staged T3-4N0M0, T1-4N+M0,-a(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

Unwilling or unable to provide informed consent
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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