Adenoid Cystic CarcinomaPhase 2EIC-SNACCNCT07320508
Epirubicin Interventional Chemotherapy for Sinonasal Adenoid Cystic Carcinoma (SNACC): A Prospective Study
A Phase 2 study testing Epirubicin (E) in people with Adenoid Cystic Carcinoma and Sinonasal Carcinoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adenoid Cystic Carcinoma, Sinonasal Carcinoma, Epirubicin
- What is being tested?
- Epirubicin (E)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 12 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital, Fudan University
Shanghai, Xuhui Strict, 200031
About this study
Official title: A Prospective, Multicenter Study of Transarterial Epirubicin Chemotherapy in the Treatment of Sinonasal Adenoid Cystic Carcinoma
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.
Read the detailed description
- 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.
- 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.
- Study Design This is a prospective, multicenter, single-arm, interventional study. The study employs a response-adapted design.
- 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.
- 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
- Being tested
- Epirubicin (E)
- Keywords
- transarterial chemoembolization, objective response rate, 2-year progression-free surviva
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Epirubicin (E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: From the start of surgery or radiotherapy until 90 days after completion of local therapy
Overall Survival (OS)
The time from the initiation of interventional chemotherapy to death from any cause.
Measured: From the start of intervention, assessed up to 5 years
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.
Measured: Tissue obtained at baseline (pre-treatment); response assessed after 3 cycles (each cycle is 28 days) of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start20 Jan 2026
- Primary completion12 Dec 2027 (estimated)
- Study completion12 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Liu, Eye & ENT Hospital of Fudan University
- Investigators
- Quan Liu, M.D., Principal investigator, Eye and ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320508
- Sponsor's protocol ID
- EyeEntFudan-2025307
- Other IDs
- 2025307
- Acronym
- EIC-SNACC
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an investigator-initiated study conducted in China. Individual participant data (IPD) contains sensitive personal health information and is subject to strict data protection regulations in China (e.g., the Personal Information Protection Law). There is currently no approved data sharing mechanism that fully complies with these regulations while ensuring participant privacy. Therefore, there is no plan to publicly share raw IPD. Aggregate results will be shared through publication in peer-reviewed journals.
Publications
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.
PubMed 8280659Zhou 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.
PubMed 40979299Teymoortash 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.
PubMed 24033920van 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.
PubMed 25456010Lupinetti 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.
PubMed 17960615Mavrikios 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.
PubMed 37097003Bjorndal 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.
PubMed 21612974Dodd 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.
PubMed 16757203
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study of Transarterial Epirubicin Chemotherapy in the Treatment of Sinonasal Adenoid Cystic Carcinoma
- ClinicalTrials.gov ID
- NCT07320508
- Acronym / sponsor ID
- EIC-SNACC / EyeEntFudan-2025307
- Conditions
- Adenoid Cystic Carcinoma, Sinonasal Carcinoma, Epirubicin
- Keywords
- transarterial chemoembolization, objective response rate, 2-year progression-free surviva
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 12 Dec 2029 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- Study Design This is a prospective, multicenter, single-arm, interventional study. The study employs a response-adapted design.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Chemotherapy with Epirubicin | Experimental | Drug: Epirubicin (E)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Interventional Chemotherapy with Epirubicin |
Primary outcome
Objective Response Rate (ORR)
Time frame: After completion of 3 cycles (each cycle is 28 days) of interventional chemotherapy (at the time of response assessment)
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.
2-year Progression-Free Survival (PFS) rate
Time frame: 2 years from the start of intervention
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.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first dose of interventional chemotherapy up to 30 days after the last dose (approximately 18 weeks)
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.
4 secondary outcomes
Complete Response (CR) Rate
Time frame: 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
Time frame: From the start of surgery or radiotherapy until 90 days after completion of local therapy
Overall Survival (OS)
Time frame: From the start of intervention, assessed up to 5 years
Correlation of Biomarker with Treatment Response
Time frame: Tissue obtained at baseline (pre-treatment); response assessed after 3 cycles (each cycle is 28 days) of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publication: PubMed 8280659Vermorken 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.
- Results publication: PubMed 40979299Zhou 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.
- Results publication: PubMed 24033920Teymoortash 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.
- Results publication: PubMed 25456010van 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.
- Results publication: PubMed 17960615Lupinetti 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.
- Results publication: PubMed 37097003Mavrikios 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.
- Results publication: PubMed 21612974Bjorndal 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.
- Results publication: PubMed 16757203Dodd 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.
- Individual participant dataSharing planned: No. This is an investigator-initiated study conducted in China. Individual participant data (IPD) contains sensitive personal health information and is subject to strict data protection regulations in China (e.g., the Personal Information Protection Law). There is currently no approved data sharing mechanism that fully complies with these regulations while ensuring participant privacy. Therefore, there is no plan to publicly share raw IPD. Aggregate results will be shared through publication in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quan Liu, M.D. principal investigator
Eye and ENT Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin (E) in people with Adenoid Cystic Carcinoma and Sinonasal Carcinoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Liu, M.D. (86+15001959681, liuqent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: After completion of 3 cycles (each cycle is 28 days) of interventional chemotherapy (at the time of response assessment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07320508, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.