Efficacy and Safety Study of PDT Using Deuteporfin for Unresectable Advanced Perihilar Cholangiocarcinoma

NCT ID: NCT02955771

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2018-12-26

Brief Summary

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.

Conditions

Hilar Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PDT-Deuteporfin（6 hour）plus stenting

Deuteporfin (7.5mg/kg) was injected intravenously 6 hours before intraluminal photoactivation (wavelength,630 nm;light dose, 180 J/cm(2)). After PDT, endoscopic or percutaneous stenting will be performed.The second treatment may be given after 3 months.

Group Type: EXPERIMENTAL

PDT-Deuteporfin（6 hour)

Intervention Type: COMBINATION_PRODUCT

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.

stenting

Intervention Type: DEVICE

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).

PDT-Deuteporfin（9 hour）plus stenting

Deuteporfin (7.5mg/kg) was injected intravenously 9 hours before intraluminal photoactivation (wavelength,630 nm;light dose, 180 J/cm(2)). After PDT, endoscopic or percutaneous stenting will be performed.The second treatment may be given after 3 months.

Group Type: EXPERIMENTAL

PDT-Deuteporfin（9 hour)

Intervention Type: COMBINATION_PRODUCT

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.

stenting

Intervention Type: DEVICE

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).

Stenting

Endoscopic or percutaneous stenting alone will be performed.

Group Type: OTHER

stenting

Intervention Type: DEVICE

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).

Interventions

PDT-Deuteporfin（6 hour)

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.

Intervention Type: COMBINATION_PRODUCT

PDT-Deuteporfin（9 hour)

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.

Intervention Type: COMBINATION_PRODUCT

stenting

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males or females aged 18 or older.
• Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage Ⅲ/Ⅳ.
• KPS≥70.
• Total Bilirubin<85.5 umol/L.
• Informed consent obtained.

Exclusion Criteria

• The first diagnosis time of cholangiocarcinoma > 3 months before randomization.
• Expected survival <3 months.
• Patients with abnormal laboratory parameters: white blood cell<3.0×10(9)/L；hemoglobin <80g/L；Neutrophil Differential Count<1.5×10(9)/L；blood platelets<75×10(9)/L；or patients have other diseases of the blood system.
• Creatinine clearance >1.5×upper limit of normal range.
• Patients with severe liver function damage，or aspartate transaminase (AST) and/or alanine transaminase (ALT) >5×upper limit of normal range.
• Patients have intrahepatic metastasis, or distant metastasis (including distant lymph node metastasis); or bile duct cancer patients with other parts of the primary malignant tumor.
• Patients have activities of viral hepatitis, liver cirrhosis, liver abscess, alcoholic fatty liver, primary hepatocellular carcinoma, and other liver diseases; or patients have immunoglobulin G4 (IgG4) sclerosing cholangitis, primary sclerosing cholangitis, autoimmune cholangitis, and other cholangitis.
• Malignancies other than cholangiocarcinoma within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer.
• Patients had received PDT treatment prior to randomization.
• Patients had received bile duct carcinoma resection prior to randomization.
• Patients had received chemotherapy, or brachytherapy，or radiotherapy prior to randomization.
• Patients had received metal stent treatment prior to randomization.
• Presence of infection (active, untreated infection and/or acute bacterial or fungal infection) other than the infection of the bile duct (cholangitis).
• Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) >180 mmHg and/or sitting diastolic blood pressure (DBP) >110 mmHg after medication]; have severe complications of hypertension or diabetes.
• Presence of severe heart, lung and central nervous system diseases.
• Presence of mental illness, or mental disorders can not accurately describe their feelings, or not according to the doctor's advice to take medication.
• History of alcohol abuse, drug abuse in the past 1 years.
• Presence of allergic diseases，or known to have light skin allergies or porphyria, or known to allergic to study drug(porphyrin drugs) or other similar compounds, cephalosporin antibiotics, other types penicillin, β lactamase inhibitors.
• Patients need to use prohibited drugs in proposal during the first 2 weeks of screening, or during the trial period.
• Patients having been enrolled in other clinical trial within 3 months prior to this clinical trial.
• Pregnant, lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
• The researchers weren't allowed to participate in this study as subjects.
• Patients unsuitable for enrollment in the clinical trial according to investigators decision.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyu Yin, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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

Countries

China

Other Identifiers

FDZJDTBF-NCC201512

Identifier Type: -

Identifier Source: org_study_id