Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma

The goal of this prospective, randomized, controlled phase II clinical study is to evaluate the efficacy and safety of neoadjuvant radiotherapy in patients with locally advanced unresectable thymoma. The main questions it aims to answer are: 1. Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ? 2. The safety and adverse reactions of neoadjuvant radiotherapy? Does the addition of neoadjuvant chemotherapy have an impact on this? Participants will be randomly divided into two groups: one group will receive neoadjuvant radiotherapy, and the other will receive neoadjuvant chemoradiotherapy. The primary endpoint of the study is to evaluate the radical resection rate (R0) of two groups. The secondary endpoints will include the pathological complete response rate (pCR), 3-year progression-free survival, and safety and toxicities. In addition, this study will explore the feasibility and completion rate of minimally invasive surgical resection.

NCT Number	NCT06924619
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Locally Advanced Thymoma
Enrollment	178 participants
Start Date	2024-10-30
Primary Completion	2026-05-01 (estimated)
Study Completion	2029-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-24