Epirubicin chemoembolization to shrink sinonasal adenoid cystic carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: liuqent@163.com
• Phone: 86+15001959681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma

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• Surgery Alone or with Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma

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• Becotatug vedotin plus epirubicin before surgery for EGFR-positive unresectable recurrent sinonasal adenoid cystic carcinoma

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• Neoadjuvant therapy with anlotinib and epirubicin for T4 sinonasal adenoid cystic carcinoma

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• Puxitatug Samrotecan (P‑Sam) for advanced, recurrent, or metastatic aggressive ACC‑I

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.