Actively Recruiting
Led by Eye & ENT Hospital of Fudan University · Updated on 2026-05-12
40
Participants Needed
1
Research Sites
91 weeks
Total Duration
Researchers are studying a new combination treatment for patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma, a type of cancer that affects the sinus and nasal areas. This prospective, multicenter, single-arm phase II clinical trial aims to find out if combining Becotatug vedotin (MRG003) with epirubicin before surgery can improve the rate of tumor shrinkage enough to allow for successful surgery or better disease control. The study is sponsored by the Eye & ENT Hospital of Fudan University and involves 40 patients. Participants receive three cycles of neoadjuvant therapy given every 21 days. Each cycle includes an intravenous infusion of Becotatug vedotin at 2.0 mg/kg and epirubicin at 75 mg/m² on the first day. After completing three cycles, patients are evaluated for tumor response and potential eligibility for surgery. The study also includes a translational research part where tumor samples are used to create organoid models to test drug sensitivity. During the study, patients undergo imaging tests to measure tumor response about 21 days after the last treatment cycle. Safety and side effects are monitored from the first dose until about 30 days after the final treatment. Surgery assessments occur within four weeks after therapy completion to evaluate surgical outcomes. Patients are then followed for up to 48 months to monitor disease control, progression-free survival, and overall survival. An independent safety board reviews the trial data after the first 20 patients are enrolled to ensure participant safety.
CONDITIONS
A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive Becotatug vedotin (MRG003) and epirubicin intravenously on day 1 of each 21-day cycle for 3 cycles as neoadjuvant therapy.
3 treatment visits (in-person), one every 21 days
Duration - Up to 4 weeks
Participants undergo surgery if the tumor becomes resectable, within 4 weeks after completing neoadjuvant therapy.
1 surgery visit and several post-operative visits
Duration - Up to 48 months
Participants are monitored for disease progression and survival after treatment completion.
Visits every 3 months for 2 years, then every 6 months up to 5 years
Total: 1 location
1
Eye & ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
Q
Quan Liu, Director
W
Wanpeng Li, mid-level
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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