RecruitingPhase 2NCT07447570

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

27 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two immunotherapy drugs — iparomlimab and tuvonralimab — together with low-dose radiation and chemotherapy in people with locally advanced head and neck squamous cell carcinoma (cancer in the mouth, throat, or nearby structures that has not yet spread to distant parts of the body). The study aims to see if this combination improves outcomes compared to standard treatment. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with Stage III–IVB head and neck squamous cell carcinoma (confirmed by biopsy) - You have not received any prior treatment for this cancer (no chemotherapy, targeted therapy, or immunotherapy) - You are in good functional health (ECOG performance status 0 or 1) - You have adequate blood counts and organ function **You may NOT be eligible if:** - You have active autoimmune disease requiring treatment, or another condition that could be worsened by immunotherapy - You have untreated or uncontrolled thyroid disease, severe infections, or active hepatitis - You have received prior immunotherapy or chemotherapy for this cancer - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIparomlimab 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.

RADIATIONHypofractionated Radiotherapy

hypofractionated radiotherapy (5 Gy × 3) for two cycles

DRUGChemotherapy

sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin)


Locations(1)

Second Affiliated Hospital Of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07447570


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