Status:
UNKNOWN
CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
Lead Sponsor:
Hangzhou Cancer Hospital
Conditions:
Esophageal Neoplasm
Esophageal Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 chemo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04481100
Start Date
October 1 2020
End Date
July 31 2023
Last Update
October 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
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, 518116