Esophageal Diseases, Esophageal Neoplasm, Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal Squamous Cell Carcinoma, Concurrent chemoradiotherapy, Itraconazole, Hedgehog pathway
Brief 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
Interventions
DRUGitraconazole
Oral administration of itraconazole twice daily concurrent with chemoradiation
Sponsors
Hangzhou Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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,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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 4-8 weeks | ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events | year 0 - year 1 | Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion. |
| Local-regional free survival (LRFS) | year 0 - year 3 | LRFS was calculated from the date of treatment initiation to the date of documented failure. |
| Overall survival (OS) | year 0 - year 3 | OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death. |
Countries
China
Contacts
Primary ContactShixiu Wu, phD
Outcome results
None listed