Clinical trial · Interventional
CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
Phase II Study of Concurrent Chemoradiotherapy With Itraconazole in Treating Patients With Locally Advanced Esophageal Squamous Cancer
NCT04481100CI-TRIAL-00047685unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Diseases | — | UNRESOLVED | — |
| Esophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.
- interventionNames
- Drug: itraconazole
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 4-8 weeks
- description
- ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1
Secondary outcomes (3)
- measure
- Treatment-emergent adverse events
- timeFrame
- year 0 - year 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.