KCT0001763招募中未知
Endoscopy (ultrasound endoscopy, retrograde pancreatic endoscopy, percutaneous transhepatic endoscopy) photodynamic therapy using next-generation photosensitizers and laser probes in patients with locally advanced pancreatic and hepatic ductal carcinoma without response to conventional therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 99(Year)（—）
- 性别
- All
入选标准
- •1) Criteria for selecting pancreatic tumor test subjects
- •? Stages that can not be operated (stage 3 ~ 4a) or systemic conditions or accompanying diseases
- •? Pancreatic cancer that progresses locally without systemic metastasis despite conventional chemotherapy
- •? Under the judgment of the researcher, patients who are deemed to need a new treatment method corresponding to 1) and 2)
- •? Those diagnosed as adenocarcinoma histologically from pancreatic cancer
- •? Women who were not menopausal or sterilized were tested for serum
- •ß-HCG negative can be used, and medically acceptable contraceptive methods should be used
- •? The Eastern Cooperative Oncology Group (ECOG)
- •? Patients aged 19 or older who understood and agreed to this study
- •2) Criteria for selection of candidates for liver cancer
- •? Cholangiocarcinoma patients who need broad-band cure
- •? Those who are unable to perform surgery due to systemic conditions or accompanying diseases.
- •? Cholangiocarcinoma progressing locally without systemic metastasis despite conventional chemotherapy
- •? Under the judgment of the researcher, patients who are deemed to need a new treatment corresponding to 1) and 2)
- •? Patients aged 19 or older who understood and agreed to this study
排除标准
- •1) criteria for excluding pancreatic tumor test subjects
- •? Under 18 years old
- •? If you can not perform endoscopic ultrasound under sedation
- •? The subject who had previously received PDT for the pancreas
- •? hemorrhagic tendency, or those with related diseases or the following laboratory
- •If you have a number
- •- PT INR> 1.5
- •- platelet <50,000
- •- WBC <2.0x10? / l
- •- hemoglobin <90 g / l
- •- Hematocrit ratio <27%
- •? Those who have acute pancreatitis accompanied by a screening criterion within 4 weeks
- •? If there is no willingness to follow up or if the patient does not agree with the procedure
- •? pregnant or lactating
- •? Those participating in other drug clinical trials before 30 days on screening basis. However,
- •Participating subjects can be registered
- •? Candidates who have known hypersensitivity to known porphyria
- •? If there are other neoplasms other than cervical intraepithelial carcinoma or skin basal cell carcinoma,
- •Subjects with a history of other neoplasms treated within 5 years
- •? Intermediate-level dysfunction with a parameter of grade 3 or higher according to the adverse reaction term standard.
- •? Cockcroft-Gault equation with calculated creatinine clearance <45 ml
- •? If the Eastern Cooperative Oncology Group (ECOG) Score is more than 3 levels
- •? Others Those who are deemed difficult to perform the clinical trial when the test taker judges
- •2) Criteria for excluding patients to be tested for cholangiocarcinoma
- •? Under 18 years old
- •? If you can not perform endoscopic ultrasound under sedation
- •? Uncorrected coagulation disorder (PT INR> 1.5, platelet <50,000)
- •? Those with acute pancreatitis
- •? If there is no willingness to follow up or if the patient does not agree with the procedure
研究者
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