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

NCT ID: NCT07320508

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2029-12-12

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.

Detailed Description

1. Background and Rationale Sinonasal adenoid cystic carcinoma (SNACC) is a rare malignancy with a propensity for perineural invasion and skull base infiltration. Complete surgical resection is challenging and often associated with significant morbidity. While systemic chemotherapy offers limited benefit, our preclinical data from patient-derived tumor organoid drug sensitivity testing identified Epirubicin as the most active agent (sensitivity rate: 87.5%, n=24).Transarterial chemoembolization allows for targeted, high-dose drug delivery to the tumor bed while minimizing systemic exposure, presenting a promising neoadjuvant strategy.

2. Study Objectives

Primary Objectives: To evaluate the objective response rate (ORR) after three cycles of transarterial Epirubicin chemoinfusion, the 2-year progression-free survival (PFS) of the integrated strategy, and the safety profile of the interventional chemotherapy.

Secondary Objectives: To assess the complete response (CR) rate post-chemotherapy, the safety of subsequent surgery/radiotherapy, overall survival (OS), and explore biomarkers predictive of response.

3. Study Design This is a prospective, multicenter, single-arm, interventional study. The study employs a response-adapted design.

4. Methodology

Participants: Approximately 100 patients with histologically confirmed, locally advanced (T3/T4) SNACC will be enrolled across multiple centers in China, including [Fudan University Eye & ENT Hospital].

Intervention: All participants will receive three cycles of transarterial Epirubicin chemoinfusion (60mg/m² per cycle, q4w). Central imaging review (MRI, RECIST 1.1) will be performed 4-6 weeks after the third cycle.

Stratified Treatment Pathways:

Path A (Non-CR): Patients not achieving CR will undergo planned skull base surgery followed by adjuvant radiotherapy.

Path B (CR): Patients achieving imaging CR will proceed directly to definitive intensity-modulated radiotherapy (IMRT) without surgery.

Assessments: Efficacy will be assessed via serial contrast-enhanced MRI. Safety will be monitored per CTCAE v5.0, including laboratory tests and cardiac function evaluation (echocardiography).

Statistical Analysis: The sample size is calculated based on demonstrating superiority in ORR compared to a historical benchmark. PFS and OS will be analyzed using the Kaplan-Meier method. Analysis will follow the intention-to-treat principle.

5. Ethics and Dissemination The study protocol has been approved by the Institutional Review Board of [Fudan University Eye & ENT Hospital] (Approval No: [2025307]). It will be conducted in accordance with the Declaration of Helsinki. Results will be disseminated through peer-reviewed publications and academic conferences.

Conditions

Adenoid Cystic Carcinoma; Sinonasal Carcinoma; Epirubicin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Epirubicin (E)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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) 9th 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Quan Liu

Senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quan Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital, Fudan University

Locations

Eye and ENT Hospital, Fudan University

Shanghai, Xuhui Strict, China

Site Status: RECRUITING

Countries

China

Central Contacts

Quan Liu, M.D.

Role: CONTACT

liuqent@163.com

86+15001959681

Wanpeng Li, M.D.

Role: CONTACT

18879117831@163.com

86+13262856870

References

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Reference Type: RESULT

PMID: 16757203 (View on PubMed)

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.

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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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.

Reference Type: RESULT

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Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2025307

Identifier Type: OTHER

Identifier Source: secondary_id

EyeEntFudan-2025307

Identifier Type: -

Identifier Source: org_study_id