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Proceedings Paper

Photochemical internalization: current clinical trials in cholangiocarcinoma (Conference Presentation)
Author(s): Hans Olivecrona M.D.

Paper Abstract

Cholangiocarcinoma (CCA) is a rare cancer, usually silent and presenting at late stage. Most common location is extrahepatic, perihilar or distal biliary adenocarcinoma. Liver function is critically affected, and biliary duct patency maintenance key for survival and life quality. Standard-of-care (SoC) in inoperable CCA (> 75%) is gemcitabine/cisplatin in 8 cycles with a response rate of <25%, and median progression free survival (PFS) and overall survival (OS) of approximately 8 and 12 months, respectively. The PCI approach is well suited in CCA; gemcitabine effects are clearly enhanced in preclinical models, and PhotoChemical Internalization can be triggered by targeted illumination during endoscopy (ERCP). In a multicenter phase I dose escalation trial with 16 patients in 4 dose cohorts (light energy and photosensitizer (fimaporfin; Amphinex®) + gemcitabine), the PCI procedure preceded standard gem/cis therapy up to 8 cycles. No dose-limiting toxicities or unexpected serious adverse reactions (SAE) emerged. The predominant SAE, cholangitis, had similar frequency, incidence pattern and severity reported previously. The two highest dose cohorts had >20% reduction in 17/19 target lesions, with 12 lesions becoming undetectable. The Duration of Response was > 12 and >15 months in the full study and highest dose cohort respectively; corresponding median OS ended at 14.4 and 21.7 months. An Extension study including a second PCI at cycle 5 demonstrated a similar safety profile. Based on these encouraging data, the RELEASE trial, a pivotal randomized trial comparing SoC chemotherapy +/- up to two PCI procedures in Europe and the United States is now starting recruitment.

Paper Details

Date Published: 14 August 2019
Proc. SPIE 11070, 17th International Photodynamic Association World Congress, 110703C (14 August 2019); doi: 10.1117/12.2528203
Show Author Affiliations
Hans Olivecrona M.D., PCI Biotech AS (Norway)

Published in SPIE Proceedings Vol. 11070:
17th International Photodynamic Association World Congress
Tayyaba Hasan, Editor(s)

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