neoadjuvant_thymic Epithelial Tumor

Thymic Epithelial Tumor Clinical Trial

Official title: A Phase II, Neo-adjuvant Pembrolizumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Pembrolizumab Consolidation Therapy in Locally Advanced Thymic Epithelial Tumor (TET)

Status Recruiting

Clinical Trial Summary

This is a Phase II single center, open-label, single arm study in patients with unresectable thymic epithelial tumors (Masaoka stage III, IVA). Patients will be treated with Pembrolizumab 200 mg, Docetaxel 75mg/m2, Cisplatin 75mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive pembrolizumab 200mg for 32 cycles. Patient who had R1 resection will receive radiation 52.8Gy/24Fx with pembrolizumab 200mg for 32 cycles. Patients who had R2 resection will receive radiation 59.4Gy/27Fx with pembrolizumab 200mg for 32 cycles. Patients who showed non-progressive disease (PD) to initial neoadjuvant therapy but remained unresectable will receive radiation 59.4Gy/27Fx with 200mg for 32 cycles. Otherwise patients are off the study.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Thymic Epithelial Tumor
• Thymus Neoplasms

• NCT number: NCT03858582
• Study type: Interventional
• Source: Samsung Medical Center
• Contact: Keunchil Park
• Phone: 82-2-3410-3459
• Email: keunchil.park@samsung.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 29, 2019
• Completion date: April 1, 2023