NCT06725498 Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC

Trial Parameters

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Brief Summary

This study pioneers a novel approach by integrating a new auxiliary chemo-immunotherapy regimen, which is then followed by an evaluation of the potential for surgical resection. For those patients who remain non-resectable, a tailored treatment plan is proposed, consisting of arterial infusion chemotherapy in conjunction with radiotherapy, succeeded by a series of immune checkpoint inhibitors. The efficacy and safety of this integrated therapeutic strategy are meticulously assessed, with the goal of enhancing survival outcomes for patients with T4bNanyM0 HNSCC.

Eligibility Criteria

Inclusion Criteria: * Patients with T4bNanyM0 Head and neck squamous cell carcinoma (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer or oral cavity) with a confirmed diagnosis by histology and/or cytology; * Expected survival ≥3 months, with adequate organ function; * Investigators believe they can safely receive treatment with PD-1 combined with platinum and albumin-bound paclitaxel; * Age ≥18 years; * ECOG score of 0-1; * Measurable disease as defined by RECIST v1.1; * Adequate bone marrow reserve and organ function: Absolute neutrophil count (ANC) ≥1,000/microliter (mcL), platelets ≥75,000/mcL, hemoglobin ≥8g/dL, without transfusion or dependence on erythropoietin (EPO) (within 7 days after assessment); * Renal function: Serum creatinine ≤1.5 times the upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥60mL/min with creatinine levels \> 1.5 times the institutional ULN. (GFR can also be used in place of creatinine or CrCl). Creatinine clearance

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