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

NCT02955771 | Terminated Phase 2

• 1 other identifier: FDZJDTBF-NCC201512
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

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

Keywords

photodynamic therapy(PDT); stenting; Hilar Cholangiocarcinoma; Deuteporfin

Outcome Measures

Primary Outcomes (1)

• Overallsurvival

  From the date of randomization until the date of death or the last date the subject was known to be alive

  Up to 12 months

Secondary Outcomes (6)

• 1-year survival rate

  Up to 12 months

• The change rate of Bile duct stricture

  Up to 6 months

• The change rate of serum bilirubin

  Up to 1 month

• The change rate of carbohydrate antigen 199(CA199)

  Up to 6 months

• The change rate of Karnofsky Performance Scale(KPS)

  Up to 12 months

Study Arms (3)

PDT-Deuteporfin（6 hour）plus stenting

EXPERIMENTAL

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.

Combination Product: PDT-Deuteporfin（6 hour); Device: stenting

PDT-Deuteporfin（9 hour）plus stenting

EXPERIMENTAL

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.

Combination Product: PDT-Deuteporfin（9 hour); Device: stenting

Stenting

OTHER

Endoscopic or percutaneous stenting alone will be performed.

Device: stenting

Interventions

PDT-Deuteporfin（6 hour) 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.

PDT-Deuteporfin（6 hour）plus stenting

PDT-Deuteporfin（9 hour) 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.

PDT-Deuteporfin（9 hour）plus stenting

stenting 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（6 hour）plus stenting; PDT-Deuteporfin（9 hour）plus stenting; Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (4)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

Shanghai Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Stents

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Xiaoyu Yin, MD. PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: May 17, 2017
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

CN (4)