NCT05801133招募中2 期
Pifenidone is Used to Reduce Radiation Lung Injury in Lung Cancer Patients Previously Treated With Immune Checkpoint Inhibitors: A Single-arm, Open-label, Phase II Study
Hubei Cancer Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2023年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)
研究概览
简要总结
Patients with advanced lung cancer who have previously received immunocheckpoint inhibitor therapy, undergone chest radiation therapy again have developed radiation induced lung injury. Pirfenidone has anti-inflammatory and anti fibrosis effects. This study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy in the prevention of radiation pneumonitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients joined the study voluntarily and signed an informed consent form (ICF). They had good compliance and cooperated with follow-up;
- •Patients with lung cancer who had received at least 2 cycles of immunomonotherapy or combination systemic therapy (including PD-1 or PD-L1 immunocheckpoint inhibitors) within 6 months;
- •Age ≥ 18 years, no gender limit;
- •ECOG PS score: 0～1;
- •The expected survival time ≥ 3 months;
- •Use appropriate methods of contraception or surgical sterilization during treatment and for 3 years after treatment for men and women of reproductive age；
- •Appropriate biochemical indicators and organ function.
排除标准
- •Currently participating in interventional clinical research and treatment, or receiving other research drugs or treatment with research equipment within 4 weeks before the first administration;
- •Accept solid organ or blood system transplantation;
- •Suffer from active autoimmune diseases that require hormone or immunomodulatory treatment, such as rheumatoid arthritis, ankylosing spondylitis, type I diabetes, psoriasis, vitiligo, immune-related thyroid dysfunction, etc. (hormone replacement Can be included after treatment is normal);
- •Suffer from acute or chronic infectious diseases, such as hepatitis B, hepatitis C, tuberculosis, and HIV;
- •Allergic to research drug ingredients;
- •Active infection or fever of unknown cause occurred during the screening period and before the first administration> 38.5℃ (according to the judgment of the investigator, the subject can be included in the group due to fever caused by the tumor);
- •Suffer from uncontrolled clinical symptoms or diseases of the heart, such as:(1) Heart failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
- •Suffer from high blood pressure and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
- •Abnormal blood coagulation function (INR>2.0, PT>16s), have a bleeding tendency or are receiving thrombolytic therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin;
- •Obvious coughing up blood or hemoptysis of 10ml or more per day in the 2 months before enrollment;
- •Have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before enrollment;
- •Have received anti-tumor monoclonal antibodies (mAb) within 4 weeks before using the study drug for the first time, or the adverse events caused by the previously received drug have not recovered (ie ≤ grade 1 or reached the baseline level). Note: Except for subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 hair loss, if the subject has undergone major surgery, the toxic reaction and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
- •The investigator judged other situations not suitable for inclusion in this study.
研究组 & 干预措施
Pirfenidone combined with radiotherapy
Experimental
Pirfenidone: synchronized with RT, 200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months
Radiotherapy: no limitation, TD≥50Gy (BED/ α/β： 10）
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)
时间窗: up to 6 month
Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)
次要结局
- Disease Control Rate （DCR）(up to 6 month)
- 6 month progression-free-survival (PFS) rate(up to 6 month)
- Treatment-related adverse events(up to 6 month)
- Objective Response Rate (ORR)(up to 6 month)
研究者
HAN GUANG
professor
Hubei Cancer Hospital
研究点 (1)
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