RecruitingPhase 2NCT07320508

Epirubicin Interventional Chemotherapy for Sinonasal Adenoid Cystic Carcinoma (SNACC): A Prospective Study

A Prospective, Multicenter Study of Transarterial Epirubicin Chemotherapy in the Treatment of Sinonasal Adenoid Cystic Carcinoma

Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

100 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Adenoid Cystic Carcinoma Sinonasal Carcinoma Epirubicin

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

Age between 18 and 70 years.
Histologically confirmed diagnosis of sinonasal adenoid cystic carcinoma (ACC).
Tumor stage T3 or T4 according to the AJCC (American Joint Committee on Cancer) 9th edition staging system. Participants with lymph node metastasis must be amenable to surgical dissection. Those with distant metastasis must have stable disease.
Ability to provide a sufficient volume (≥0.5 cm³) of fresh tumor tissue via biopsy or surgery for research purposes, with participant's informed consent.
ECOG (Eastern Cooperative Oncology Group) performance status score of 0 to 2.
Voluntary participation and provision of written informed consent. Good compliance, able to cooperate with treatment and follow-up.

Exclusion Criteria8

Prior treatment with Epirubicin or any other anthracycline-based chemotherapy.
Prior radiotherapy to the head and neck region.
Administration of any other chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to study enrollment.
Concurrent participation in another interventional drug clinical trial.
Inadequate liver, kidney, or bone marrow function that does not meet the requirements for the planned treatment regimen.
Contraindications to anthracycline-containing chemotherapy regimens: known allergy to anthracyclines, presence of ≥ Grade 2 peripheral neuropathy, or uncontrolled nausea/vomiting or chronic gastrointestinal diseases.
Severe uncontrolled acute infection or decompensated major organ dysfunction.
Pregnancy or lactation.

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Interventions

DRUGEpirubicin (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.