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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called pirfenidone to see if it can help make radiation therapy more effective for patients with head and neck squamous cell carcinoma (HNSCC), a common type of cancer in that area. Researchers have found that some types of cells in tumors can make them less sensitive to radiation, which can lead to a higher chance of the cancer coming back. By using pirfenidone, they hope to reduce the effects of these cells and improve treatment outcomes.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of HNSCC that has not been previously treated with radiation. You should also be in generally good health, as your organ function will be checked before starting the study. Participants will receive treatment with pirfenidone alongside radiation therapy and will be monitored for safety and effectiveness. This trial is currently recruiting and aims to help improve treatment options for patients facing this challenging cancer.

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Eligibility 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."