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.
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.).
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.
Single group
Anlotinib + Epirubicin
DrugAnlotinib 10 mg orally once daily on days 1-14 of each 21-day cycle (2 weeks on, 1 week off) for 2 cycles.
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.
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).
R0 Resection Rate
Proportion of participants undergoing surgery who achieve microscopically negative margins (no tumor cells at the resection margin on final pathology).
Overall Survival
Time from enrollment to death from any cause. Participants who are alive at last follow-up will be censored.
Local Control Rate
Proportion of participants without local recurrence (at primary tumor site) at specified time points.
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