Adenoid Cystic CarcinomaPhase 2NAET4-SNACCNCT07616141
Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma
A Phase 2 study testing Anlotinib Hydrochloride and Epirubicin in people with Adenoid Cystic Carcinoma, run by Eye & ENT Hospital of Fudan University at 5 sites in China.
Trial summary
T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenoid Cystic Carcinoma
- What is being tested?
- Anlotinib Hydrochloride and Epirubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jun 2026to 1 Jun 2031
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, any sex.
- Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype).
- Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable.
- Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate bone marrow, liver, kidney, and cardiac function: absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; ALT/AST ≤2.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN; creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; left ventricular ejection fraction (LVEF) ≥50%.
- Willing to participate and able to provide written informed consent (including for clinical treatment and translational research).
Who cannot join
- Prior radiotherapy to the head and neck region.
- Prior anthracycline therapy with cumulative dose ≥300 mg/m².
- Known hypersensitivity to any component of anlotinib or epirubicin.
- Uncontrolled hypertension, severe cardiovascular disease, or active infection.
- Pregnant or breastfeeding women.
- Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study compliance or conduct.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Zhenlin Wang, MD, wzl1812@163.com ext. 010-83198899, wzl1812@163.com
- Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Zhaohui Shi, MD, 020-85253333, zhaohuishi@139.com
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yan Jiang, MD, 0532-82911847, jiangyanoto@163.com
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030
Xinsheng Huang, MD, 021-64041990, huang.xinsheng@zs-hospital.sh.cn
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Quan Liu, MD, +86 15001959681, liuqent@163.com
About this study
Official title: Neoadjuvant Anlotinib Combined With Epirubicin for T4 Stage Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial
T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. The goal of this study is to test whether a new combination of drugs given before surgery - anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug) - can improve outcomes for patients with T4 SNACC.
This is a prospective, multicenter, single-arm, phase II clinical trial. Eligible participants will receive 2 cycles of neoadjuvant treatment (anlotinib orally for 2 weeks on/1 week off, plus epirubicin intravenously on day 1 of each 3-week cycle). After completing neoadjuvant therapy, participants will undergo surgery to remove the tumor, followed by postoperative radiotherapy. The main question the study tries to answer is whether this approach increases the 3-year progression-free survival (PFS) rate compared to the historical rate of about 70% with standard treatment (surgery plus radiotherapy alone). Secondary questions include how many tumors shrink after neoadjuvant treatment, how many operations achieve complete removal with negative margins, major pathological response rates, overall survival, safety, quality of life, and the chance of avoiding disfiguring surgeries (such as removal of the eye or part of the skull). The study will enroll about 76 participants from 5 top medical centers in China. If positive, this study may establish a new standard of care for T4 SNACC.
Read the detailed description
Sinonasal adenoid cystic carcinoma (SNACC) is a rare cancer. T4 stage tumors often invade the skull base, orbit, or dura, making complete surgical removal difficult. Even with surgery and radiotherapy, the 3-year progression-free survival (PFS) is only about 70%, and extensive resection may cause disfigurement or loss of function.
This is a prospective, multicenter, single-arm, phase II trial. Eligible patients will receive 2 cycles of neoadjuvant therapy (anlotinib 10 mg orally on days 1-14 plus epirubicin 70 mg/m² IV on day 1, 21-day cycle). After neoadjuvant treatment, patients undergo surgery followed by postoperative radiotherapy.
The primary endpoint is 3-year PFS rate, compared with the historical rate of 70%. Secondary endpoints include objective response rate, R0 resection rate, major pathological response, overall survival, safety, quality of life, and organ preservation rate. Exploratory endpoints include biomarkers, ctDNA dynamics, and organoid drug sensitivity.
Target sample size is 76 patients from 5 Chinese centers. The study has been approved by the Institutional Review Board of Eye \& ENT Hospital of Fudan University (approval number 2026069-1). Written informed consent will be obtained from all participants.
- Conditions
- Adenoid Cystic Carcinoma
- Being tested
- Anlotinib Hydrochloride, Epirubicin
- Keywords
- Adenoid Cystic Carcinoma, Sinonasal, T4 Stage, Neoadjuvant Therapy, Anlotinib, Epirubicin, Prospective Study, Phase II Clinical Trial
- 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.
Anlotinib HydrochlorideDrug
Anlotinib 10 mg orally once daily on days 1-14 of each 21-day cycle (2 weeks on, 1 week off) for 2 cycles.
EpirubicinDrug
Epirubicin 70 mg/m² intravenous infusion on day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Anlotinib + Epirubicin | Experimental | Participants receive neoadjuvant therapy for 2 cycles (each cycle is 21 days). Anlotinib 10 mg orally once daily on days 1-14 (2 weeks on, 1 week off). Epirubicin 70 mg/m² intravenous infusion on day 1 of each cycle. After completion of neoadjuvant therapy, participants undergo radical surgery followed by postoperative radiotherapy as per protocol. Receives: Drug: Anlotinib Hydrochloride; Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Progression-Free Survival
Progression-free survival (PFS) is defined as the time from enrollment to the first documentation of disease progression (local recurrence, regional recurrence, or distant metastasis) or death from any cause, whichever occurs first. The 3-year PFS rate is the proportion of participants who remain alive and free from disease progression at 3 years after enrollment.
Measured: From enrollment to 3 years post-enrollment (assessed every 3 months for the first 2 years, then every 6 months) or until progression or death
Secondary outcomes (7)
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) after neoadjuvant therapy, assessed by RECIST v1.1 (blinded independent central review).
Measured: At week 6 (after completion of 2 cycles of neoadjuvant therapy, before surgery)
R0 Resection Rate
Proportion of participants undergoing surgery who achieve microscopically negative margins (no tumor cells at the resection margin on final pathology).
Measured: At time of surgery (approximately week 10-12 after enrollment)
Overall Survival
Time from enrollment to death from any cause. Participants who are alive at last follow-up will be censored.
Measured: From enrollment up to 5 years (assessed every 3 months for first 2 years, then every 6 months)
Local Control Rate
Proportion of participants without local recurrence (at primary tumor site) at specified time points.
Measured: At 1 year, 2 years, and 3 years post-enrollment
Adverse events
Incidence, type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) assessed by CTCAE version 5.0.
Measured: From first dose of study drug until 30 days after last dose or surgery, whichever is later
EORTC QLQ-C30
Change from baseline in EORTC QLQ-C30 physical functioning scale score. The EORTC QLQ-C30 physical functioning scale ranges from 0 to 100, with higher scores indicating better physical functioning.
Measured: Baseline, at week 6 (after neoadjuvant therapy), at 6 months, 12 months, 24 months, and 36 months post-enrollment
Organ Preservation Rate
Proportion of participants who avoid disfiguring surgeries including orbital exenteration, maxillectomy, craniotomy, or skull base resection compared to hypothetical initial surgery without neoadjuvant therapy.
Measured: At time of surgery (approximately week 10-12 after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Interventional Study Model
- Masking
- None (open label)
- Enrolment
- 76 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616141
- Sponsor's protocol ID
- 2026069-1
- Acronym
- NAET4-SNACC
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to concerns about participant privacy and limitations of informed consent.
Publications
Hanna GJ, Ahn MJ, Muzaffar J, Keam B, Bowles DW, Wong DJ, Ho AL, Kim SB, Worden F, Yun T, Meng X, Van Tornout JM, Conlan MG, Kang H. A Phase II Trial of Rivoceranib, an Oral Vascular Endothelial Growth Factor Receptor 2 Inhibitor, for Recurrent or Metastatic Adenoid Cystic Carcinoma. Clin Cancer Res. 2023 Nov 14;29(22):4555-4563. doi: 10.1158/1078-0432.CCR-23-1030.
PubMed 37643133Lupinetti 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 17960615Michel G, Joubert M, Delemazure AS, Espitalier F, Durand N, Malard O. Adenoid cystic carcinoma of the paranasal sinuses: retrospective series and review of the literature. Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Nov;130(5):257-62. doi: 10.1016/j.anorl.2012.09.010. Epub 2013 Jun 6.
PubMed 23747147Song X, Sun J, Yang G, Wang X, Wang L. Long-term outcomes of platinum-based chemotherapy for T4 stage sinonasal adenoid cystic carcinoma. Front Pharmacol. 2025 Sep 29;16:1623242. doi: 10.3389/fphar.2025.1623242. eCollection 2025.
PubMed 41089828Mauthe T, Holzmann D, Soyka MB, Mueller SA, Balermpas P, Held U, Freiberger SN, Rupp NJ, Meerwein CM. Overall and disease-specific survival of sinonasal adenoid cystic carcinoma: a systematic review and meta-analysis. Rhinology. 2023 Dec 1;61(6):508-518. doi: 10.4193/Rhin23.204.
PubMed 37703531Cavalieri S, Mariani L, Vander Poorten V, Van Breda L, Cau MC, Lo Vullo S, Alfieri S, Resteghini C, Bergamini C, Orlandi E, Calareso G, Clement P, Hauben E, Platini F, Bossi P, Licitra L, Locati LD. Prognostic nomogram in patients with metastatic adenoid cystic carcinoma of the salivary glands. Eur J Cancer. 2020 Sep;136:35-42. doi: 10.1016/j.ejca.2020.05.013. Epub 2020 Jul 3.
PubMed 32629365Seok J, Lee DY, Kim WS, Jeong WJ, Chung EJ, Jung YH, Kwon SK, Kwon TK, Sung MW, Ahn SH. Lung metastasis in adenoid cystic carcinoma of the head and neck. Head Neck. 2019 Nov;41(11):3976-3983. doi: 10.1002/hed.25942. Epub 2019 Aug 29.
PubMed 31463986Mavrikios 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Anlotinib Combined With Epirubicin for T4 Stage Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07616141
- Acronym / sponsor ID
- NAET4-SNACC / 2026069-1
- Conditions
- Adenoid Cystic Carcinoma
- Keywords
- Adenoid Cystic Carcinoma, Sinonasal, T4 Stage, Neoadjuvant Therapy, Anlotinib, Epirubicin, Prospective Study, Phase II Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 1 Jun 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.
T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. The goal of this study is to test whether a new combination of drugs given before surgery - anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug) - can improve outcomes for patients with T4 SNACC.
This is a prospective, multicenter, single-arm, phase II clinical trial. Eligible participants will receive 2 cycles of neoadjuvant treatment (anlotinib orally for 2 weeks on/1 week off, plus epirubicin intravenously on day 1 of each 3-week cycle). After completing neoadjuvant therapy, participants will undergo surgery to remove the tumor, followed by postoperative radiotherapy. The main question the study tries to answer is whether this approach increases the 3-year progression-free survival (PFS) rate compared to the historical rate of about 70% with standard treatment (surgery plus radiotherapy alone). Secondary questions include how many tumors shrink after neoadjuvant treatment, how many operations achieve complete removal with negative margins, major pathological response rates, overall survival, safety, quality of life, and the chance of avoiding disfiguring surgeries (such as removal of the eye or part of the skull). The study will enroll about 76 participants from 5 top medical centers in China. If positive, this study may establish a new standard of care for T4 SNACC.
Detailed description
Sinonasal adenoid cystic carcinoma (SNACC) is a rare cancer. T4 stage tumors often invade the skull base, orbit, or dura, making complete surgical removal difficult. Even with surgery and radiotherapy, the 3-year progression-free survival (PFS) is only about 70%, and extensive resection may cause disfigurement or loss of function.
This is a prospective, multicenter, single-arm, phase II trial. Eligible patients will receive 2 cycles of neoadjuvant therapy (anlotinib 10 mg orally on days 1-14 plus epirubicin 70 mg/m² IV on day 1, 21-day cycle). After neoadjuvant treatment, patients undergo surgery followed by postoperative radiotherapy.
The primary endpoint is 3-year PFS rate, compared with the historical rate of 70%. Secondary endpoints include objective response rate, R0 resection rate, major pathological response, overall survival, safety, quality of life, and organ preservation rate. Exploratory endpoints include biomarkers, ctDNA dynamics, and organoid drug sensitivity.
Target sample size is 76 patients from 5 Chinese centers. The study has been approved by the Institutional Review Board of Eye \& ENT Hospital of Fudan University (approval number 2026069-1). Written informed consent will be obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional Study Model
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Anlotinib + Epirubicin | Experimental | Drug: Anlotinib Hydrochloride, Drug: EpirubicinParticipants receive neoadjuvant therapy for 2 cycles (each cycle is 21 days). Anlotinib 10 mg orally once daily on days 1-14 (2 weeks on, 1 week off). Epirubicin 70 mg/m² intravenous infusion on day 1 of each cycle. After completion of neoadjuvant therapy, participants undergo radical surgery followed by postoperative radiotherapy as per protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 years, any sex.
- Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype).
- Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable.
- Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (6 listed)
- Prior radiotherapy to the head and neck region.
- Prior anthracycline therapy with cumulative dose ≥300 mg/m².
- Known hypersensitivity to any component of anlotinib or epirubicin.
- Uncontrolled hypertension, severe cardiovascular disease, or active infection.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Anlotinib HydrochlorideAnlotinib 10 mg orally once daily on days 1-14 of each 21-day cycle (2 weeks on, 1 week off) for 2 cycles. | Drug | Neoadjuvant Anlotinib + Epirubicin |
| EpirubicinEpirubicin 70 mg/m² intravenous infusion on day 1 of each cycle. | Drug | Neoadjuvant Anlotinib + Epirubicin |
Primary outcome
3-Year Progression-Free Survival
Time frame: From enrollment to 3 years post-enrollment (assessed every 3 months for the first 2 years, then every 6 months) or until progression or death
Progression-free survival (PFS) is defined as the time from enrollment to the first documentation of disease progression (local recurrence, regional recurrence, or distant metastasis) or death from any cause, whichever occurs first. The 3-year PFS rate is the proportion of participants who remain alive and free from disease progression at 3 years after enrollment.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: At week 6 (after completion of 2 cycles of neoadjuvant therapy, before surgery)
R0 Resection Rate
Time frame: At time of surgery (approximately week 10-12 after enrollment)
Overall Survival
Time frame: From enrollment up to 5 years (assessed every 3 months for first 2 years, then every 6 months)
Local Control Rate
Time frame: At 1 year, 2 years, and 3 years post-enrollment
Adverse events
Time frame: From first dose of study drug until 30 days after last dose or surgery, whichever is later
EORTC QLQ-C30
Time frame: Baseline, at week 6 (after neoadjuvant therapy), at 6 months, 12 months, 24 months, and 36 months post-enrollment
Organ Preservation Rate
Time frame: At time of surgery (approximately week 10-12 after enrollment)
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 3 Nov 2026.
- Results publication: PubMed 37643133Hanna GJ, Ahn MJ, Muzaffar J, Keam B, Bowles DW, Wong DJ, Ho AL, Kim SB, Worden F, Yun T, Meng X, Van Tornout JM, Conlan MG, Kang H. A Phase II Trial of Rivoceranib, an Oral Vascular Endothelial Growth Factor Receptor 2 Inhibitor, for Recurrent or Metastatic Adenoid Cystic Carcinoma. Clin Cancer Res. 2023 Nov 14;29(22):4555-4563. doi: 10.1158/1078-0432.CCR-23-1030.
- 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 23747147Michel G, Joubert M, Delemazure AS, Espitalier F, Durand N, Malard O. Adenoid cystic carcinoma of the paranasal sinuses: retrospective series and review of the literature. Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Nov;130(5):257-62. doi: 10.1016/j.anorl.2012.09.010. Epub 2013 Jun 6.
- Results publication: PubMed 41089828Song X, Sun J, Yang G, Wang X, Wang L. Long-term outcomes of platinum-based chemotherapy for T4 stage sinonasal adenoid cystic carcinoma. Front Pharmacol. 2025 Sep 29;16:1623242. doi: 10.3389/fphar.2025.1623242. eCollection 2025.
- Results publication: PubMed 37703531Mauthe T, Holzmann D, Soyka MB, Mueller SA, Balermpas P, Held U, Freiberger SN, Rupp NJ, Meerwein CM. Overall and disease-specific survival of sinonasal adenoid cystic carcinoma: a systematic review and meta-analysis. Rhinology. 2023 Dec 1;61(6):508-518. doi: 10.4193/Rhin23.204.
- Results publication: PubMed 32629365Cavalieri S, Mariani L, Vander Poorten V, Van Breda L, Cau MC, Lo Vullo S, Alfieri S, Resteghini C, Bergamini C, Orlandi E, Calareso G, Clement P, Hauben E, Platini F, Bossi P, Licitra L, Locati LD. Prognostic nomogram in patients with metastatic adenoid cystic carcinoma of the salivary glands. Eur J Cancer. 2020 Sep;136:35-42. doi: 10.1016/j.ejca.2020.05.013. Epub 2020 Jul 3.
- Results publication: PubMed 31463986Seok J, Lee DY, Kim WS, Jeong WJ, Chung EJ, Jung YH, Kwon SK, Kwon TK, Sung MW, Ahn SH. Lung metastasis in adenoid cystic carcinoma of the head and neck. Head Neck. 2019 Nov;41(11):3976-3983. doi: 10.1002/hed.25942. Epub 2019 Aug 29.
- 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. IPD will not be shared due to concerns about participant privacy and limitations of informed consent.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Hydrochloride and Epirubicin in people with Adenoid Cystic Carcinoma, run by Eye & ENT Hospital of Fudan University at 5 sites 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 7 inclusion and 6 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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, MD (+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?
3-Year Progression-Free Survival (time frame: From enrollment to 3 years post-enrollment (assessed every 3 months for the first 2 years, then every 6 months) or until progression or death). 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 NCT07616141, which also lists 10 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 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.