Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
研究概览
简要总结
To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.
详细描述
Photodynamic therapy (PDT) is a way of producing tissue necrosis with light after prior administration of a photosensitizing agent. The most important advantages include the possibility of combining PDT with other target therapies and repeat the process as needed with a favorable outcomes. The combination of diverse therapeutic modalities is one of the new strategies to enhance oncologic treatments for pancreatic cancer. In order to overcome the limitations of each treatment modalities and to prevent the development of resistance, the application of PDT combined with target therapies, without increasing the toxicity for the patient, is being widely investigated.
PDT has been only extensively studied for the treatment of various superficial skin cancers in the Europe but not available in the United States and Japan due to the overlapping treatment fields. In Korea, the use of first-generation and second-generation photosensitizers are part of the study of Gastroenterology, Dermatology, Otolaryngology, and Gynecology.
Recently, although the investigators have introduced PDT using novel photosensitizers has not yet been used for the treatment of pancreatic cancers. This study aim to determine the safety and efficacy of photodynamic therapy with a novel photosensitizer in locally advanced hilar cholangiocarcinoma.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection
- •Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center
- •Pathologically proven cholangiocarcinoma
- •have a negative pregnancy test if appropriate
- •ECOG(Eastern Cooperative Oncology Group) Score 0-2
- •patients to give informed consent and age more than >19 years
排除标准
- •age less than 18 years
- •previous history of PDT
- •uncorrectable coagulopathy
- •refuse to participate
- •recent participation in another clinical research trial within 30 days
- •presence of porphyria or hypersensitivity to photosensitizer
- •Creatinine clearance < 45ml
结局指标
主要结局
Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
时间窗: within 1 month
Response Evaluation Criteria in Solid Tumours (RECIST) criteria
次要结局
- Adverse events and overall survival(within 1 week)
研究者
Do Hyun Park
Associate Professor
Asan Medical Center