RecruitingPhase 2NCT06725498

Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC

A Prospective, Single-center, Open-label Phase II Clinical Study of Intra-arterial Chemotherapy Combined with Concurrent Radiotherapy and Tislelizumab-jsgr in the Treatment of T4bNanyM0 HNSCC

Sponsor

Beijing Tongren Hospital

Enrollment

50 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether delivering chemotherapy directly into the arteries supplying the tumor (intra-arterial chemotherapy) combined with radiation and immunotherapy can treat advanced, inoperable head and neck squamous cell cancers more effectively. **You may be eligible if...** - Have stage T4b (very advanced, not surgically removable) head and neck squamous cell carcinoma — specifically hypopharynx, larynx, oropharynx, or oral cavity cancer - Diagnosis confirmed by tissue biopsy - Life expectancy of at least 3 months with adequate organ function - Able to perform basic daily activities **You may NOT be eligible if...** - Cancer has spread to distant organs - Have already received certain prior treatments that overlap with this regimen - Have serious cardiovascular, liver, kidney, or other organ problems - 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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