Adenoid Cystic Carcinoma Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Eye and ENT Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Quan Liu, M.D.
liuqent@163.com
86+15001959681
Backup
Wanpeng Li, M.D.
18879117831@163.com
86+13262856870
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2029-12-12
Participants
Target number of participants: 100
Treatments
Experimental: Interventional Chemotherapy with Epirubicin
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.
Related Therapeutic Areas
Sponsors
Leads: Eye & ENT Hospital of Fudan University

This content was sourced from clinicaltrials.gov