A Phase 2 interventional study of Epirubicin (E) in Adenoid Cystic Carcinoma, Sinonasal Carcinoma and Epirubicin, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Eye & ENT Hospital of Fudan University · Phase 2, Interventional, and Treatment
This study is for patients with locally advanced sinonasal adenoid cystic carcinoma (SNACC), a rare and challenging cancer that tends to invade nerves and the skull base. The research aims to test a new precise treatment strategy. First, all participants will receive three sessions of "interventional chemotherapy" (transarterial chemoembolization) with the drug Epirubicin, which delivers high-dose chemotherapy directly to the tumor to shrink it as much as possible. About 4-6 weeks after the third session, doctors will use MRI scans to evaluate how well the tumor responded. Based on this response, patients will follow one of two personalized treatment paths: those whose tumors did not completely disappear will undergo surgery followed by radiotherapy; those whose tumors show complete disappearance on imaging will receive precise radiotherapy alone, potentially avoiding major surgery. This is a prospective, multicenter study. The main goals are to evaluate the safety and effectiveness of this response-adapted strategy and to see if it can improve outcomes for patients with this difficult-to-treat cancer.
Study Objectives
Primary Objectives: To evaluate the objective response rate (ORR) after three cycles of transarterial Epirubicin chemoinfusion, the 2-year progression-free survival (PFS) of the integrated strategy, and the safety profile of the interventional chemotherapy.
Secondary Objectives: To assess the complete response (CR) rate post-chemotherapy, the safety of subsequent surgery/radiotherapy, overall survival (OS), and explore biomarkers predictive of response.
Methodology
Participants: Approximately 100 patients with histologically confirmed, locally advanced (T3/T4) SNACC will be enrolled across multiple centers in China, including [Fudan University Eye \& ENT Hospital].
Intervention: All participants will receive three cycles of transarterial Epirubicin chemoinfusion (60mg/m² per cycle, q4w). Central imaging review (MRI, RECIST 1.1) will be performed 4-6 weeks after the third cycle.
Stratified Treatment Pathways:
Path A (Non-CR): Patients not achieving CR will undergo planned skull base surgery followed by adjuvant radiotherapy.
Path B (CR): Patients achieving imaging CR will proceed directly to definitive intensity-modulated radiotherapy (IMRT) without surgery.
Assessments: Efficacy will be assessed via serial contrast-enhanced MRI. Safety will be monitored per CTCAE v5.0, including laboratory tests and cardiac function evaluation (echocardiography).
Statistical Analysis: The sample size is calculated based on demonstrating superiority in ORR compared to a historical benchmark. PFS and OS will be analyzed using the Kaplan-Meier method. Analysis will follow the intention-to-treat principle.
102 studies on the registry are indexed under Carcinoma, Adenoid Cystic; 23 are open to participants now.
This study's planned enrollment of 100 is above the median of 35 across 93 interventional studies indexed under Carcinoma, Adenoid Cystic.
Browse Carcinoma, Adenoid Cystic studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
All participants in this single-arm study will undergo three cycles of transarterial Epirubicin chemoinfusion (60mg/m² per cycle, every 4 weeks) as the initial intervention. Following this, the imaging assessment (MRI, RECIST 1.1) will be performed. Participants will then be assigned to one of two predefined local therapy pathways based on their tumor response: those not achieving a complete response (CR) will undergo skull base surgery followed by radiotherapy; those achieving CR will receive definitive radiotherapy alone.
Drug: Epirubicin (E)
Epirubicin is administered via transarterial chemoinfusion (TAI) as a neoadjuvant treatment. The drug is delivered at a dose of 60 mg/m² per cycle, diluted in normal saline at a concentration of 1 mg:1 mL. The infusion is performed through super-selective catheterization of the tumor-feeding arteries under angiographic guidance. This cycle is repeated every 4 weeks for a total of 3 cycles prior to response assessment and subsequent stratified local therapy.
Objective Response Rate (ORR)
The proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, as assessed by central imaging review after completion of interventional chemotherapy.
Time frame: After completion of 3 cycles (each cycle is 28 days) of interventional chemotherapy (at the time of response assessment)
2-year Progression-Free Survival (PFS) rate
The proportion of participants alive without disease progression (local recurrence or distant metastasis) at 2 years from the initiation of interventional chemotherapy. Progression is defined per RECIST 1.1 criteria.
Time frame: 2 years from the start of intervention
Incidence of Treatment-Emergent Adverse Events (TEAEs)
The frequency and severity of adverse events assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, specifically related to the interventional chemotherapy phase.
Time frame: From the first dose of interventional chemotherapy up to 30 days after the last dose (approximately 18 weeks)
Complete Response (CR) Rate
The proportion of participants achieving complete response (CR) according to RECIST 1.1 criteria, as assessed by central imaging review after completion of interventional chemotherapy.
Time frame: After completion of 3 cycles ((each cycle is 28 days) ) of interventional chemotherapy (at the time of response assessment)
Incidence of Adverse Events related to Surgery and Radiotherapy
The frequency and severity of adverse events assessed as per CTCAE v5.0, that are attributable to the subsequent local therapy (surgery and/or radiotherapy) phase of the integrated treatment.
Time frame: From the start of surgery or radiotherapy until 90 days after completion of local therapy
Overall Survival (OS)
The time from the initiation of interventional chemotherapy to death from any cause.
Time frame: From the start of intervention, assessed up to 5 years
Correlation of Biomarker with Treatment Response
An exploratory analysis to assess the association between molecular characteristics (e.g., from tumor tissue) and objective response to Epirubicin interventional chemotherapy.
Time frame: Tissue obtained at baseline (pre-treatment); response assessed after 3 cycles (each cycle is 28 days) of chemotherapy
Plan to share: No — This is an investigator-initiated study conducted in China. Individual participant data (IPD) contains sensitive personal health information and is subject to strict data protection regulations in China (e.g., the Personal Information Protection Law). There is currently no approved data sharing mechanism that fully complies with these regulations while ensuring participant privacy. Therefore, there is no plan to publicly share raw IPD. Aggregate results will be shared through publication in peer-reviewed journals.
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Eye & ENT Hospital of Fudan University