Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma
NCT ID: NCT06142318
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2023-11-15
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pirfenidone group
Calculate from 2 weeks before the start of radiotherapy: week 1: pirfenidone 200mg, tid; week 2: pirfenidone 400mg tid; during radiotherapy: pirfenidone 600mg tid.
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.
Control group
Calculate from 2 weeks before the start of radiotherapy: week 1: placebo 200mg, tid; week 2: placebo 400mg tid; during radiotherapy: placebo 600mg tid.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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."
18 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Southern medical university
Guangzhou, Guangdong, China
Fujian Provinical Hospital
Fuzhou, , 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, , China
Countries
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Facility Contacts
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Yongmei Dai
Role: primary
Yunming Tian
Role: primary
Peibao Lai
Role: primary
Jianda Sun
Role: primary
Other Identifiers
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NFEC-2023-477
Identifier Type: -
Identifier Source: org_study_id