NCT04481100

CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer

Phase II Study of Concurrent Chemoradiotherapy With Itraconazole in Treating Patients With Locally Advanced Esophageal Squamous Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Hangzhou Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Esophageal Neoplasm
• Esophageal Diseases
• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	itraconazole	Oral administration of itraconazole twice daily concurrent with chemoradiation

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-07-31
• Completion: 2023-07-31
• First posted: 2020-07-22
• Last updated: 2020-10-14

Locations

1 site across 1 country: China