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RECRUITING
NCT07320508
PHASE2

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

Sponsor: Eye & ENT Hospital of Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-20

Completion Date

2029-12-12

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

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.

Locations (1)

Eye and ENT Hospital, Fudan University

Shanghai, Xuhui Strict, China