Epirubicin chemoembolization to shrink sinonasal adenoid cystic carcinoma

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

This treatment tries three sessions of targeted transarterial Epirubicin chemoembolization in people with locally advanced sinonasal adenoid cystic carcinoma to shrink tumors and decide if surgery can be avoided.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Xuhui Strict)
• Trial ID: NCT07320508 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, single-arm Phase 2 study plans to enroll about 100 patients with locally advanced (T3/T4) sinonasal adenoid cystic carcinoma across centers in China, led by the Eye & ENT Hospital of Fudan University. Participants receive three sessions of transarterial chemoembolization delivering high-dose Epirubicin directly to the tumor, with MRI performed 4–6 weeks after the third session to measure response. Patients with complete disappearance on imaging will proceed to precise radiotherapy alone, while those without complete response will undergo surgery followed by radiotherapy in a response-adapted design. Primary endpoints are objective response rate after the three chemoembolization cycles, two-year progression-free survival of the integrated strategy, and safety, with secondary endpoints including complete response rate, overall survival, and biomarker exploration.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed, locally advanced (T3/T4) sinonasal adenoid cystic carcinoma, ECOG 0–2, able to provide fresh tumor tissue and attend interventional treatments, and without prior anthracycline chemotherapy or prior head and neck radiotherapy.

Not a fit: Patients with prior anthracycline treatment, prior head and neck radiotherapy, poor performance status (ECOG >2), unstable distant metastases, or those unable to undergo intra-arterial procedures are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could shrink tumors enough for some patients to avoid major skull-base surgery and preserve function while improving local control.

How similar studies have performed: Chemoembolization has shown benefit in other tumor types and the choice of Epirubicin is supported by patient-derived organoid sensitivity data, but transarterial Epirubicin specifically for SNACC is a novel and largely untested approach.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 70 years.
2. Histologically confirmed diagnosis of sinonasal adenoid cystic carcinoma (ACC).
3. Tumor stage T3 or T4 according to the AJCC (American Joint Committee on Cancer) 8th edition staging system. Participants with lymph node metastasis must be amenable to surgical dissection. Those with distant metastasis must have stable disease.
4. 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.
5. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 to 2.
6. Voluntary participation and provision of written informed consent. Good compliance, able to cooperate with treatment and follow-up.

Exclusion Criteria:

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

Where this trial is running

Shanghai, Xuhui Strict

• Eye and ENT Hospital, Fudan University — Shanghai, Xuhui Strict, China (Recruiting)

Study contacts

• Principal investigator: Quan Liu, M.D. — Eye and ENT Hospital, Fudan University
• Study coordinator: Quan Liu, M.D.

Conditions Adenoid Cystic Carcinoma; Sinonasal Carcinoma; Epirubicin; transarterial chemoembolization; objective response rate; 2-year progression-free surviva