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

NCT07041788 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Second Affiliated Hospital of Nanchang University

    lead OTHER

Principal Investigators

  • Lei Zeng · Second Affiliated Hospital of Nanchang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2028-07-09
Completion
2030-07-09

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07041788 on ClinicalTrials.gov