This is a multi-center, randomized, controlled, open-label, phase IIa clinical study.The study will observe the efficacy and safety of Deuteporfin photodynamic therapy in addition to stenting compared to stenting alone in patients with unresectable advanced Perihilar Cholangiocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Photodynamic therapy (PDT) involves the i.v. injection of Deuteporfin (7.5 mg/kg,Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd,Shanghai,China) followed by the illumination of the tumor. 6 hours after the injection,a laser light ( (wavelength,630 nm; light dose, 180 J/cm(2);Guilin Xingda Photoelectric Medical Calinstrument Co., Ltd,,Fujian, China) will be applied to the tumor.The second courses of PDT may be given at 3-month intervals.
Photodynamic therapy (PDT) involves the i.v. injection of Deuteporfin (7.5 mg/kg,Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd,Shanghai,China) followed by the illumination of the tumor.9 hours after the injection,a laser light ( (wavelength,630 nm; light dose, 180 J/cm(2);Guilin Xingda Photoelectric Medical Calinstrument Co., Ltd,,Fujian, China) will be applied to the tumor. The second courses of PDT may be given at 3-month intervals.
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Shanghai Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China
Overallsurvival
From the date of randomization until the date of death or the last date the subject was known to be alive
Time frame: Up to 12 months
1-year survival rate
From the date of randomization until the date of death or the last date the subject was known to be alive
Time frame: Up to 12 months
The change rate of Bile duct stricture
The date at the phase of baseline,at the end of first month, third month and sixth month
Time frame: Up to 6 months
The change rate of serum bilirubin
The date at the phase of baseline,at the first week ,at the end of first month
Time frame: Up to 1 month
The change rate of carbohydrate antigen 199(CA199)
The date at the phase of baseline,at the end of first month, third month and sixth month
Time frame: Up to 6 months
The change rate of Karnofsky Performance Scale(KPS)
From the date of randomization until the date of death or the last date the subject was known to be alive
Time frame: Up to 12 months
The change rate of European Organization for Research and Treatment of Cancer Quality Of Life Questionnaire C30 (EORTC QLQ-C30)
From the date of randomization until the date of death or the last date the subject was known to be alive
Time frame: Up to 12 months
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The stenting procedure consists in the placement of plastic stents (Boston Scientific Corporation, MA,USA;or Cook Medical, Bloomington,USA)above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC).