CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481100
• Other study ID #: 20200707
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2020
• Source: Hangzhou Cancer Hospital
• Contact: Shixiu Wu, phD
• Phone: 86-755-66618168
• Email: wushixiu[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Diseases
• Esophageal Neoplasm
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• itraconazole
Oral administration of itraconazole twice daily concurrent with chemoradiation

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1	4-8 weeks
Secondary	Treatment-emergent adverse events	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.	year 0 - year 1
Secondary	Local-regional free survival (LRFS)	LRFS was calculated from the date of treatment initiation to the date of documented failure.	year 0 - year 3
Secondary	Overall survival (OS)	OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.	year 0 - year 3