drugset / Trial / NCT06142318

Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma

NCT06142318

Phase 2 Unknown 66 enrolled Nanfang Hospital, Southern Medical University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide, with a 5-year survival rate of less than 50%. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck squamous cell carcinoma, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%, and the distant metastasis rate is as high as 20%-30%. This is associated with a lower radiosensitivity in HNSCC. Our previous study has confirmed that type I collagen secreted by cancer-associated fibroblasts (CAFs) can enhance the radioresistance of head and neck squamous cell carcinoma. We also confirmed that pirfenidone could reduce type I collagen expression in CAFs and enhance radiosensitivity in vitro and in vivo. Therefore, we plan to translate the basic research into clinical practice and conduct a prospective interventional phase II clinical trial to investigate the safety and efficacy of pirfenidone as a radiosensitizer in HNSCC.

Timeline

Start
2023-11-15
Primary completion
2025-01-30
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pirfenidone Small molecule 600 mg