Epirubicin Interventional Chemotherapy for Sinonasal Adenoid Cystic Carcinoma (SNACC): A Prospective Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Epirubicin (E)
DrugEpirubicin 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Interventional Chemotherapy with EpirubicinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
After completion of 3 cycles (each cycle is 28 days) of interventional chemotherapy (at the time of response assessment)2
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.
Time frame
2 years from the start of intervention3
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.
Time frame
From the first dose of interventional chemotherapy up to 30 days after the last dose (approximately 18 weeks)Secondary outcomes
1
Complete Response (CR) Rate
The proportion of participants achieving complete response (CR) according to RECIST 1.1 criteria, as assessed by central imaging review after completion of interventional chemotherapy.
Time frame
After completion of 3 cycles ((each cycle is 28 days) ) of interventional chemotherapy (at the time of response assessment)2
Incidence of Adverse Events related to Surgery and Radiotherapy
The frequency and severity of adverse events assessed as per CTCAE v5.0, that are attributable to the subsequent local therapy (surgery and/or radiotherapy) phase of the integrated treatment.
Time frame
From the start of surgery or radiotherapy until 90 days after completion of local therapy3
Overall Survival (OS)
The time from the initiation of interventional chemotherapy to death from any cause.
Time frame
From the start of intervention, assessed up to 5 years4
Correlation of Biomarker with Treatment Response
An exploratory analysis to assess the association between molecular characteristics (e.g., from tumor tissue) and objective response to Epirubicin interventional chemotherapy.
Time frame
Tissue obtained at baseline (pre-treatment); response assessed after 3 cycles (each cycle is 28 days) of chemotherapySponsors and contacts
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Source ClinicalTrials.gov