Using Pirfenidone to Enhance Radiotherapy for Head and Neck Cancer
Application of Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma: Phase II Clinical Study
This study is testing if adding pirfenidone to radiotherapy can help people with head and neck cancer respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT06142318 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of pirfenidone as a radiosensitizer in patients with head and neck squamous cell carcinoma (HNSCC). The study aims to improve the effectiveness of radiotherapy by reducing the radioresistance associated with this type of cancer. Eligible participants will receive either pirfenidone or a placebo, and their responses will be monitored to assess safety and efficacy. The trial is designed to translate previous laboratory findings into clinical practice, potentially leading to better treatment outcomes for patients with HNSCC.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed head and neck squamous cell carcinoma who have not undergone prior radiotherapy.
Not a fit: Patients with contraindications to radiotherapy or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the effectiveness of radiotherapy in treating head and neck cancer, potentially reducing recurrence rates.
How similar studies have performed: Previous studies have shown promising results using similar radiosensitizing approaches, but this specific application of pirfenidone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. be at least 18 years old; 2. provide written informed consent; 3. head and neck squamous cell carcinoma confirmed by biopsy (2022 WHO criteria); 4. no previous head and neck radiotherapy; 5. The presence of measurable lesions: no surgical treatment or postoperative imaging evaluation indicated that the tumor was not completely resected; 6. ECOG PS: 0/1; 7. Laboratory confirmation of good organ function. It should be given within 10 days before the first dose of treatment; 8) expected survival time ≥3 months. Exclusion Criteria: 1. no indications for or contraindications to radiotherapy after evaluation; 2. no oral medication; 3. pregnancy or lactation; 4. patients with known allergy to pirfenidone or other contraindications; 5. concurrent tumors (except cured basal cell or squamous cell skin cancer, and cervical cancer in situ); 6. patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. "For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor condition, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), and mental illness."
Where this trial is running
Guangzhou, Guangdong and 4 other locations
- Southern medical university — Guangzhou, Guangdong, China (Recruiting)
- Fujian Provinical Hospital — Fuzhou, China (Not_yet_recruiting)
- Huizhou Central People's Hospital — Huizhou, China (Not_yet_recruiting)
- Jieyang people's hospital — Jieyang, China (Not_yet_recruiting)
- Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou, China (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.