Clinical Trials Directory

Trials / Unknown

UnknownNCT06142318

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

Application of Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma: Phase II Clinical Study

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
66 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPirfenidoneDose climbing started two weeks before the start of radiotherapy, and the maintenance dose of 600mg bid was reached in the third week until the end of radiotherapy.
DRUGPlaceboDose climbing started two weeks before the start of radiotherapy, and the maintenance dose of 600mg bid was reached in the third week until the end of radiotherapy.

Timeline

Start date
2023-11-15
Primary completion
2025-01-30
Completion
2025-06-30
First posted
2023-11-21
Last updated
2023-11-21

Locations

5 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06142318. Inclusion in this directory is not an endorsement.