Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers

• Status: Recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

Summary

In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents in patients with inoperable bile duct cancers. In addition as a preliminary study we sought to determine if the treatment can reduce tumor volume in the short term.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Temoporfin

Criteria

Inclusion Criteria:

• Patients with inoperable cholangiocarcinoma belonging to all Bismuth Corlette classification.

• Karnofsky index >30%

• Satisfactory relief of jaundice (serum bilirubin < 100µmol/L) with biliary prostheses inserted either at ERCP or via percutaneous transhepatic routes.

• Absence of biliary sepsis

• Age 18-80

• Provision of written consent

• No evidence of metastatic disease

Exclusion Criteria:

• Porphyria

• Previous inserted metallic biliary stents

• Refusal to provide a written consent.

• Moribund from disseminated disease or comorbidities

• Pregnant or lactating women