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

Study Objectives 1. Primary Objective: The core aim of this study is to investigate whether the sequential approach of Spatially Fractionated Radiotherapy followed by 3 cycles of induction chemotherapy combined with Iparomlimab and Tuvonralimab, definitive chemoradiotherapy, and maintenance therapy with the Iparomlimab and Tuvonralimab can improve the 2-year event-free survival (EFS) rate in patients with locoregionally advanced bulky head and neck squamous cell carcinoma (HNSCC). 2. Secondary Objectives:s To analyze the impact of this integrated treatment regimen on key efficacy endpoints, including: Objective response rate (ORR), Duration of response (DoR), Distant metastasis-free survival (DMFS), Local region recurrence-free survival (LRRFS), Overall survival (OS)。 2. Study Endpoints (1) Primary Endpoint and Definition: 2-Year Event-Free Survival (EFS) Rate (2) Secondary Endpoints and Definitions: 1. 2-Year Overall Survival (OS) Rate 2. 2-Year Distant Metastasis-Free Survival (DMFS) Rate. 3. 2-Year Local Region Recurrence-Free Survival (LRRFS) Rate. 4. Objective Response Rate (ORR). 5. Duration of Response (DoR). 6. Quality of Life (QoL): Assessed across multiple domains: Physical Function: Measured via tools like the 6-minute walk test or ADL (Activities of Daily Living) scale. Psychological Status: Evaluated using instruments such as HAMD (Hamilton Anxiety and Depression Scale) or MMSE (Mini-Mental State Examination). Social Function: Assessed via social engagement questionnaires (e.g., HAQ-DI \[Health Assessment Questionnaire-Disability Index\]). Spiritual Well-being: Evaluated using tools like PIL (Purpose in Life test). Clinically meaningful improvements in these domains before and after treatment define successful QoL endpoints (e.g., positive changes in physical, psychological, social, and spiritual health in cardiac patients). 7. Safety: The nature and severity of adverse reactions associated with the treatment. 8. Tolerability: The degree to which patients can endure treatment-related side effects.

NCT Number	NCT07041788
Lead Sponsor	Second Affiliated Hospital of Nanchang University Collaborators: Qilu Pharmaceutical Co., Ltd.
Conditions	Cancer
Enrollment	25 participants
Start Date	2026-04-28
Primary Completion	2028-07-09 (estimated)
Study Completion	2030-07-09 (estimated)
Updated on ClinicalTrials.gov	2026-04-30