Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04481100
Other study ID # 20200707
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06056336 - Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma Phase 2
Suspended NCT04084158 - A Study of Toripalimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma. Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Not yet recruiting NCT05561699 - Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer N/A
Active, not recruiting NCT04543617 - A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy Phase 3
Recruiting NCT06190782 - Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor Phase 3
Completed NCT05557955 - Identification of Breath Biomarkers in Esophageal Cancer
Recruiting NCT04045496 - A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Not yet recruiting NCT03766178 - Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT02913066 - S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT02399306 - Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma Phase 3
Completed NCT01605305 - Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer Phase 2
Not yet recruiting NCT05552651 - Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT05520619 - Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002) Phase 2
Terminated NCT03251417 - Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT05990231 - Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of PD-1 Combined With Platinum-containing Chemotherapy Phase 2
Recruiting NCT04644250 - Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT02916511 - Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2