NCT07447570 Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC
| NCT ID | NCT07447570 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. Signed a written informed consent form and understands and agrees to comply with the study requirements and visit schedule. 2. Male or female subjects aged ≥18 and ≤75 years at the time of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 4. Histologically or cytologically confirmed stage III-IVB head and neck squamous cell carcinoma as assessed by the investigator. 5. No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors). 6. At least one measurable target lesion per RECIST v1.1 criteria. 7. Estimated life expectancy ≥12 weeks. 8. Adequate bone marrow and organ function (without receiving any cellular products, blood components, colony-stimulating factors, or cytokine therapy within 14 days prior to laboratory testing): 1. Hematology: ANC
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