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Trial Title:
Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06142318
Condition:
Head and Neck Squamous Cell Carcinoma
Radiotherapy
Radiosensitizer
Pirfenidone
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pirfenidone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Pirfenidone
Description:
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.
Arm group label:
Pirfenidone group
Intervention type:
Drug
Intervention name:
Placebo
Description:
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.
Arm group label:
Control group
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.
Criteria for 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."
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern medical university
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, M.D.
Phone:
86+13632102247
Email:
guanjian5461@163.com
Investigator:
Last name:
Jian Guan, M.D.
Email:
Principal Investigator
Facility:
Name:
Fujian Provinical Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yongmei Dai
Facility:
Name:
Huizhou Central People's Hospital
Address:
City:
Huizhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yunming Tian
Facility:
Name:
Jieyang people's hospital
Address:
City:
Jieyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Peibao Lai
Facility:
Name:
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Address:
City:
Meizhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianda Sun
Start date:
November 15, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06142318
