114
Participants
Start Date
July 25, 2023
Primary Completion Date
August 31, 2025
Study Completion Date
August 31, 2026
definitive radiotherapy
Participants were treated with definitive thoracic radiotherapy
induction chemo-immunotherapy
All participants receive two cycles of albumin-bound paclitaxel (260mg/m2) on d1 and cisplatin (25mg/m2) from d1 to d3 in combination with tislelizumab (200mg) on d1.
concurrent chemotherapy
Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and cisplatin (25mg/m2).
Immunotheapy consolidation
Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2 pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months.
Thymosin Alpha1
"Participants in the Tα1 treatment group will receive Tα1 from the beginning of induction chemo-immunotherapy until the completion of immunotherapy consolidation. In detail, Tα-1 would be administered according to the following three stages:~1. Induction chemo-immunotherapy: Tα-1 will be subcutaneously administered at 4.8 mg on d1 and d3 for each cycle.~2. Concurrent chemoradiotherapy: Tα-1 will be subcutaneously administered at 4.8mg biweekly.~3. Immunotherpay consolidation: Tα-1 will be administered concurrently with tislelizumab at 4.8mg (Q3W) for up to 12 months."
RECRUITING
Sun yat-sen university cancer center, Guangzhou
Sun Yat-sen University
OTHER