Abstract 4285
Background
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.
Methods
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.
Results
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).
Conclusions
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
NCT01900158.
Legal entity responsible for the study
PCI Biotech AS.
Funding
PCI Biotech AS.
Editorial Acknowledgement
Disclosure
A. Högset, L. Finnesand, H. Olivecrona: Employee: PCI Biotech AS. All other authors have declared no conflicts of interest.
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