Multi-center, Randomized, Controlled, Open-label Study of Deuteporfin Photodynamic Therapy Plus Stenting Versus Stenting Alone as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.4 sites in 1 country7 target enrollmentMay 17, 2017

ConditionsHilar Cholangiocarcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hilar Cholangiocarcinoma
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Enrollment: 7
Locations: 4
Primary Endpoint: Overallsurvival
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 17, 2017

End Date

December 26, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

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.
•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.

Outcomes

Primary Outcomes

Overallsurvival

Time Frame: Up to 12 months

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

Secondary Outcomes

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)
The change rate of European Organization for Research and Treatment of Cancer Quality Of Life Questionnaire C30 (EORTC QLQ-C30)(Up to 12 months)