CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
- Conditions
- Esophageal DiseasesEsophageal NeoplasmEsophageal Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT04481100
- Lead Sponsor
- Hangzhou Cancer Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 38
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Group itraconazole Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
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