Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer: a Single-center, Single-arm, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and reducing the concentration of copper with copper chelator help to overcome radioresistance. Therefore, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine (a common copper chelator) as a radiosensitizer in the treatment of recurrent head and neck cancer.
详细描述
Head and neck cancer is the sixth most common cancer worldwide. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck cancer, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%. This is associated with a lower radiosensitivity in head and neck cancer. High doses of reirradiation (>60 Gy) are associated with severe late complications and treatment-related mortality. Therefore, finding an appropriate sensitizer to improve the radiosensitivity is the key to improve the survival of recurrent patients. Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and the results were published in J Hepatol (IF=25.7). Penicillamine is a commonly used copper chelator in clinical practice and can reduce the concentration of copper in the body. Based on this, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine as a radiosensitizer in the treatment of recurrent head and neck cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent
- •The age is 18-75 years
- •Previously received standard radical radiotherapy or chemoradiotherapy
- •Head and neck tumors with in situ or cervical lymph node recurrence confirmed by pathological biopsy and imaging examination
- •ECOG PS：0/1
- •Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.
排除标准
- •After evaluation, it does not meet the indications of re-radiotherapy
- •Unable to take oral medication
- •Pregnancy or lactation
- •Known allergy to penicillamine
- •Patients who are judged by the researcher as unsuitable to participate in this trial.
研究组 & 干预措施
Penicillamine group
Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation.
干预措施: Penicillamine (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 1 month
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.
次要结局
- Incidence of Treatment-Emergent Adverse Events(During treatment and 12 weeks after penicillamine treatment)
- local-relapse free survival (LRFS)(2 years)
- Overall survival (OS)(2 years)