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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4285 - PhotoChemical Internalization of gemcitabine followed by gemcitabine/cisplatin in perihilar cholangiocarcinoma – results from a phase I dose escalation trial


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology


Clinical Research

Tumour Site

Hepatobiliary Cancers


Jörg Trojan


Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282


J. Trojan1, R. Sturgess2, D. Harrison Palmer3, B. Neu4, S. Kasper5, A. Dechene6, C. Jürgensen7, J. Schirra8, R. Jakobs9, A. Högset10, L. Finnesand11, H. Olivecrona11

Author affiliations

  • 1 Gas­tro­in­tes­ti­na­le On­ko­lo­gie, Goethe University Medical Center, 60590 - Frankfurt am Main/DE
  • 2 The Aintree Digestive Diseases Unit, University Hospital Aintree, L9 7AL - Liverpool/GB
  • 3 Institute Of Translational Medicine, University of Liverpool Cancer Research UK Centre, L3 9TA - London/GB
  • 4 Medizinische Klinik Ii - Gastroenterologie, Hepatologie Und Onkologie, Krankenhaus Landshut-Achdorf, 84036 - Landshut/DE
  • 5 Medical Oncology, University Hospital Essen Westdeutsches Tumorzentrum, 45122 - Essen/DE
  • 6 Gastroenterology And Hepatology, University Hospital Essen Westdeutsches Tumorzentrum, 45122 - Essen/DE
  • 7 Medizinische Klinik Ii - Gastroenterologiekologie, Charité, 10117 - Berlin/DE
  • 8 Medizinische Klinik Und Poliklinik Ii, Klinikum der Ludwig-Maximilians-Universität, 81377 - Munich/DE
  • 9 Medical Department C, Klinikum Ludwigshafen, D-67063 - Ludwigshafen/DE
  • 10 Cso, PCI Biotech AS, 0379 - Oslo/NO
  • 11 Clinical Development, PCI Biotech AS, 0379 - Oslo/NO


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Abstract 4285


Cholangiocarcinoma is a rare cancer with a poor survival and an approximate response rate of 26% and a median PFS/OS of 8.0 and 11.7months respectively with current standard treatment (gemcitabine/cisplatin). Photochemical Internalisation (PCI) is a novel technology that utilizes wave-length specific light (652nm) and a photosensitizer (TPCS2a ; Amphinex®) to enhance the local therapeutic effect of a variety of molecules, including gemcitabine.


This was a Phase I, dose escalation, multicenter trial of a single PCI induction of gemcitabine (1000 mg/m2) in 16 patients with inoperable perihilar cholangiocarcinoma (CCA). Following the procedure, patients received standard therapy with gem/cis for up to 8 cycles. Patients were on-study for 6 months, and are currently followed for survival. Adverse events, including biliary complications, and tumor effects were characterized.


A total of 16 patients were treated in four different dose cohorts. 11 patients completed the 8 cycles of combination therapy; 5 patients were early withdrawals. PCI of gemcitabine was well tolerated with no Dose Limiting Toxicities, and with a general safety profile characteristic of the patient population included. At 6 months, in the two highest dose cohorts independent reading showed that 7 out of 8 patients had radiologically evaluable tumours. Of these, 2 were complete and 2 partial responses, with one stable disease. In 17/19 target lesions before treatment, a > 20% reduction in tumour size was seen, with 12 lesions undetectable at 6 months. Median OS ended at 14.4 months. As of March 2018, 4 of the 16 patients are alive 24.3 to 38.8 months after treatment (overall study average 17.4 months).


In this dose escalation trial of PCI of gemcitabine in perihilar CCA patients, a safe and tolerable dose of light and Amphinex® was established. The overall safety profile and promising results, including a proportion of patients with highly durable objective tumor response, are encouraging. A larger, controlled and randomized study is underway.

Clinical trial identification


Legal entity responsible for the study

PCI Biotech AS.


PCI Biotech AS.

Editorial Acknowledgement


A. Högset, L. Finnesand, H. Olivecrona: Employee: PCI Biotech AS. All other authors have declared no conflicts of interest.

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