Neoadjuvant therapy with anlotinib and epirubicin for T4 sinonasal adenoid cystic carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase II study enrolling adults with resectable but high-risk T4 sinonasal adenoid cystic carcinoma. Participants receive two cycles of neoadjuvant therapy: anlotinib taken orally for 14 days followed by a 7-day rest, and epirubicin given IV on day 1 of a 21-day cycle. After neoadjuvant treatment, patients undergo surgical tumor removal and then postoperative radiotherapy. The primary endpoint is the 3-year progression-free survival compared with a historical rate of 70%; secondary endpoints include response rate, resection status, overall survival, safety, quality of life, and organ preservation. Exploratory endpoints include biomarkers, ctDNA dynamics, and organoid drug sensitivity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• The Third Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Not yet recruiting
• The Affiliated Hospital of Qingdao University
  Qingdao, Shandong, China Not yet recruiting
• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Quan Liu, MD
• Email: liuqent@163.com
• Phone: +86 15001959681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.