Induction Chemotherapy and Tazemetostat for Locally Advanced SMARCB1-deficient Sinonasal Carcinoma
Status:
Not yet recruiting
Trial end date:
2027-08-31
Target enrollment:
Participant gender:
Summary
SMARCB1-deficient sinonasal carcinoma is very locally advanced malignancy at diagnosis which
often precluded upfront radical resection. We are now proposing a phase II single-arm study
on tazemetostat in combination with docetaxel, cisplatin and 5-FU (known as TPF regimen) as
preoperative therapy for locally advanced non-metastatic SMARCB1 (INI-1)-deficient sinonasal
carcinoma, followed by radical resection and/or post-operative radiation therapy (with or
without concurrent chemotherapy), and tazemetostat for another 6 months. We hypothesize that
addition of tazemetostat will improve objective response rate, resectability rate, orbit
preservation rate after surgery (, and hopefully survival outcomes with manageable safety
profiles.