25
Participants
Start Date
July 10, 2025
Primary Completion Date
July 9, 2028
Study Completion Date
July 9, 2030
Iparomlimab and Tuvonralimab Injection
"Induction Therapy:~Spatially Fractionated Radiotherapy: Administer 10-20 Gy in a single fraction to the tumor.~Chemotherapy + Immunotherapy:~Docetaxel 75 mg/m² IV on Day 1. Cisplatin 25 mg/m² IV on Days 1-3. Iparomlimab and Tuvonralimab Injection 5 mg/kg IV on Day 1. Cycles: Every 3 weeks (Q3W) for 3 cycles.~Maintenance Therapy:~Begin 4-6 weeks after radiotherapy completion.~Iparomlimab and Tuvonralimab:~Dose: 5 mg/kg diluted in 100 mL 0.9% NaCl or 5% glucose. Administration: IV infusion over ≥20 minutes (total duration including flushing ≤60 minutes).~Cycles: Q3W for 14 cycles (maximum 1 year).~Iparomlimab and Tuvonralimab Injection:~Continue until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, or investigator decision to discontinue.~Maximum treatment duration: 1 year."
The Second Affiliated Hospital of Nanchang University, Nanchang
Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Second Affiliated Hospital of Nanchang University
OTHER