NCT06725498

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab-jsgr	200mg, Q3W
DRUG	Cisplatin	60-75 mg/㎡, Q3W
DRUG	Albumin-Bound Paclitaxel	260 mg/㎡, Q3W
RADIATION	Radiotherapy	Radical Radiotherapy or adjuvant Radiotherapy per guidelines.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-11-30
• Completion: 2029-11-30
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

1 site across 1 country: China