Status:
UNKNOWN
Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Head and Neck Squamous Cell Carcinoma
Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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....
Eligibility Criteria
Inclusion
- be at least 18 years old;
- provide written informed consent;
- head and neck squamous cell carcinoma confirmed by biopsy (2022 WHO criteria);
- no previous head and neck radiotherapy;
- The presence of measurable lesions: no surgical treatment or postoperative imaging evaluation indicated that the tumor was not completely resected;
- ECOG PS: 0/1;
- 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
- no indications for or contraindications to radiotherapy after evaluation;
- no oral medication;
- pregnancy or lactation;
- patients with known allergy to pirfenidone or other contraindications;
- concurrent tumors (except cured basal cell or squamous cell skin cancer, and cervical cancer in situ);
- 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."
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06142318
Start Date
November 15 2023
End Date
June 30 2025
Last Update
November 21 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern medical university
Guangzhou, Guangdong, China, 510515
2
Fujian Provinical Hospital
Fuzhou, China
3
Huizhou Central People's Hospital
Huizhou, China
4
Jieyang people's hospital
Jieyang, China