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

NCT07320508 | Recruiting Phase 2 DMC

• 2 other identifiers: EyeEntFudan-20253072025307
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenoid Cystic Carcinoma; Sinonasal Carcinoma; Epirubicin

Keywords

transarterial chemoembolization; objective response rate; 2-year progression-free surviva

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  The proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, as assessed by central imaging review after completion of interventional chemotherapy.

  After completion of 3 cycles (each cycle is 28 days) of interventional chemotherapy (at the time of response assessment)

• 2-year Progression-Free Survival (PFS) rate

  The proportion of participants alive without disease progression (local recurrence or distant metastasis) at 2 years from the initiation of interventional chemotherapy. Progression is defined per RECIST 1.1 criteria.

  2 years from the start of intervention

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  The frequency and severity of adverse events assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, specifically related to the interventional chemotherapy phase.

  From the first dose of interventional chemotherapy up to 30 days after the last dose (approximately 18 weeks)

Secondary Outcomes (4)

• Complete Response (CR) Rate

  After completion of 3 cycles ((each cycle is 28 days) ) of interventional chemotherapy (at the time of response assessment)

• Incidence of Adverse Events related to Surgery and Radiotherapy

  From the start of surgery or radiotherapy until 90 days after completion of local therapy

• Overall Survival (OS)

  From the start of intervention, assessed up to 5 years

• Correlation of Biomarker with Treatment Response

  Tissue obtained at baseline (pre-treatment); response assessed after 3 cycles (each cycle is 28 days) of chemotherapy

Study Arms (1)

Interventional Chemotherapy with Epirubicin

EXPERIMENTAL

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.

Drug: Epirubicin (E)

Interventions

Epirubicin (E) DRUG

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.

Interventional Chemotherapy with Epirubicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) 8th 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye and ENT Hospital, Fudan University

Shanghai, Xuhui Strict, 200031, China

RECRUITING

Related Publications (8)

• Vermorken JB, Verweij J, de Mulder PH, Cognetti F, Clavel M, Rodenhuis S, Kirkpatrick A, Snow GB. Epirubicin in patients with advanced or recurrent adenoid cystic carcinoma of the head and neck: a phase II study of the EORTC Head and Neck Cancer Cooperative Group. Ann Oncol. 1993 Nov;4(9):785-8. doi: 10.1093/oxfordjournals.annonc.a058665.

  PMID: 8280659 RESULT

• Zhou J, Yu Z, Wang S, Li N. Practical guideline for recurrent or metastatic adenoid cystic carcinoma. Innovation (Camb). 2025 May 21;6(9):100957. doi: 10.1016/j.xinn.2025.100957. eCollection 2025 Sep 8. No abstract available.

  PMID: 40979299 RESULT

• Teymoortash A, Zieger L, Hoch S, Pagenstecher A, Hofer MJ. Distinct microscopic features of perineural invasion in adenoid cystic carcinoma of the head and neck. Histopathology. 2014 Jun;64(7):1037-9. doi: 10.1111/his.12210. Epub 2013 Aug 19. No abstract available.

  PMID: 24033920 RESULT

• van Weert S, van der Waal I, Witte BI, Leemans CR, Bloemena E. Histopathological grading of adenoid cystic carcinoma of the head and neck: analysis of currently used grading systems and proposal for a simplified grading scheme. Oral Oncol. 2015 Jan;51(1):71-6. doi: 10.1016/j.oraloncology.2014.10.007. Epub 2014 Oct 28.

  PMID: 25456010 RESULT

• Lupinetti AD, Roberts DB, Williams MD, Kupferman ME, Rosenthal DI, Demonte F, El-Naggar A, Weber RS, Hanna EY. Sinonasal adenoid cystic carcinoma: the M. D. Anderson Cancer Center experience. Cancer. 2007 Dec 15;110(12):2726-31. doi: 10.1002/cncr.23096.

  PMID: 17960615 RESULT

• Mavrikios A, Goudjil F, Beddok A, Zefkili S, Bolle S, Feuvret L, Le Tourneau C, Choussy O, Sauvaget E, Herman P, Dendale R, Calugaru V. Proton therapy and/or helical tomotherapy for locally advanced sinonasal skull base adenoid cystic carcinoma: Focus on experience of the Institut Curie and review of literature. Head Neck. 2023 Jul;45(7):1619-1631. doi: 10.1002/hed.27371. Epub 2023 Apr 25.

  PMID: 37097003 RESULT

• Bjorndal K, Krogdahl A, Therkildsen MH, Overgaard J, Johansen J, Kristensen CA, Homoe P, Sorensen CH, Andersen E, Bundgaard T, Primdahl H, Lambertsen K, Andersen LJ, Godballe C. Salivary gland carcinoma in Denmark 1990-2005: a national study of incidence, site and histology. Results of the Danish Head and Neck Cancer Group (DAHANCA). Oral Oncol. 2011 Jul;47(7):677-82. doi: 10.1016/j.oraloncology.2011.04.020. Epub 2011 May 25.

  PMID: 21612974 RESULT

• Dodd RL, Slevin NJ. Salivary gland adenoid cystic carcinoma: a review of chemotherapy and molecular therapies. Oral Oncol. 2006 Sep;42(8):759-69. doi: 10.1016/j.oraloncology.2006.01.001. Epub 2006 Jun 6.

  PMID: 16757203 RESULT

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Epirubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Quan Liu, M.D.

  Eye and ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quan Liu, M.D.

CONTACT

86+15001959681; liuqent@163.com

Wanpeng Li, M.D.

CONTACT

86+13262856870; 18879117831@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. The assignment to subsequent local therapy is based on objective imaging assessment (RECIST 1.1).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior doctor

Model Details: This is a single-arm, response-adapted study. All enrolled participants will first receive the same interventional chemotherapy. After central imaging assessment, they will be assigned to one of two predefined, stratified local therapy pathways based on their objective tumor response (complete response or not), as per protocol.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 6, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 12, 2027
• Study Completion (Estimated): December 12, 2029
• Last Updated: May 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)