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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Application of Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma: Phase II Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142318
• Other study ID #: NFEC-2023-477
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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."

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Pirfenidone
• Radiotherapy
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Pirfenidone
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.
• 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.

Locations

Country	Name	City	State
China	Fujian Provinical Hospital	Fuzhou
China	Southern medical university	Guangzhou	Guangdong
China	Huizhou Central People's Hospital	Huizhou
China	Jieyang people's hospital	Jieyang
China	Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou	Meizhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	2 years
Primary	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.	1 month
Secondary	Overall survival (OS)	OS was defined as the time from the date of inclusion until death from any cause.	2 years
Secondary	Incidence of Treatment-Emergent Adverse Events	treatment-related adverse events will be assessed by CTCAE v5.0	During treatment and 12 weeks after treatment