Iparomlimab and Tuvonralimab Combined With SFRT and Definitive Chemoradiotherapy in Locoregionally Advanced Bulky HNSCC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 10, 2025

Primary Completion Date

July 9, 2028

Study Completion Date

July 9, 2030

Conditions
Cancer
Interventions
DRUG

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."

Trial Locations (1)

330006

The Second Affiliated Hospital of Nanchang University, Nanchang

All Listed Sponsors
collaborator

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

lead

Second Affiliated Hospital of Nanchang University

OTHER