NCT07447570

Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC

Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multicenter, Single-arm, Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Head and neck squamous cell carcinoma (HNSCC) is often diagnosed at a locally advanced stage, where cisplatin-based chemoradiotherapy is standard but still results in high recurrence rates. Immunotherapy is promising for HNSCC due to its high mutational burden, and adding PD-1 inhibitors to induction chemotherapy has improved responses without added toxicity. Radiotherapy can further stimulate antitumor immunity. Iparomlimab and Tuvonralimab, a dual anti-PD-1/CTLA-4 antibody, has shown strong activity across several solid tumors, and early studies suggest synergy with hypofractionated radiotherapy. However, evidence in locally advanced HNSCC is lacking. The investigators therefore propose a multicenter, single-arm phase II trial to assess the efficacy and safety of combining Iparomlimab and Tuvonralimab injection with chemoradiotherapy in locoregionally advanced HNSCC.

Conditions

• Head and Neck Cancer
• Radiotherapy
• Anti-PD-1/CTLA-4 Antibody

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab injection	Induction therapy include Iparomlimab and Tuvonralimab injection combined with hypofractionated radiotherapy (5 Gy × 3) for two cycles, followed by sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin). After completing chemoradiotherapy, patients receive maintenance Iparomlimab and Tuvonralimab injection for at least six months.
RADIATION	Hypofractionated Radiotherapy	hypofractionated radiotherapy (5 Gy × 3) for two cycles
DRUG	Chemotherapy	sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin)

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: China