Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma

Sponsor
Eye & ENT Hospital of Fudan University
Study ID
NCT07616141
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib + Epirubicin — DRUG
    Anlotinib 10 mg orally once daily on days 1-14 of each 21-day cycle (2 weeks on, 1 week off) for 2 cycles.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2031

Study Design

Enrollment
76 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Anlotinib + Epirubicin
    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.

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 ]

Central Contacts

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