A Phase 2 interventional study of Pirfenidone and Placebo in Head and Neck Squamous Cell Carcinoma, Radiotherapy and Radiosensitizer, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 66 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
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Exclusion Criteria:
Calculate from 2 weeks before the start of radiotherapy: week 1: pirfenidone 200mg, tid; week 2: pirfenidone 400mg tid; during radiotherapy: pirfenidone 600mg tid.
Drug: Pirfenidone
Calculate from 2 weeks before the start of radiotherapy: week 1: placebo 200mg, tid; week 2: placebo 400mg tid; during radiotherapy: placebo 600mg tid.
Drug: Placebo
Dose 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.
Dose 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.
Objective response rate (ORR)
The objective response rate (ORR) is the proportion of patients who achieve a prespecified reduction in tumor volume that is maintained for a minimum duration. The objective response rate was defined as the sum of complete response plus partial response (CR+PR). According to RECIST1.1 criteria, CR was defined as the disappearance of target lesions and the reduction of the short diameter of pathological lymph nodes to less than 10mm. PR: the sum of the measured diameters of the target lesions reduced by 30% compared with the baseline; PD: the sum of the major diameters of all target lesions increased by at least 20%, and the absolute value of the sum of the major diameters increased by more than 5mm, or new lesions appeared. SD: Changes between PR and PD.
Time frame: 1 month
Overall survival (OS)
OS was defined as the time from the date of inclusion until death from any cause.
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events
treatment-related adverse events will be assessed by CTCAE v5.0
Time frame: During treatment and 12 weeks after treatment
the biomarkers correlated with ORR and OS
The correlations between ORR, OS and cancer associated fibroblasts, collagen type I, PD-L1 expression in tissues, tumor mutation burden, tumor-related gene changes, plasma cytokines or other biomarkers were explored.
Time frame: 2 years
Plan to share: No
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Nanfang Hospital, Southern Medical University