Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\< 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability/preferences, as HAI-FUDR/DEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution.
Data from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR/DEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR/DEX. The efficacy and safety of the two treatment groups, HAI-FUDR/DEX and SIRT, will be compared in a parallel cohort (non-randomized) design
Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection.
A tumour that is technically not resectable with R0 margins (i.e. where resection will not yield an FLR of sufficient size and function) without reconstruction of portal or liver vein, or artery.
Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions
Recurrent tumour following resection
Any non-liver malignant deposit (except for resectable, hilar lymph nodes)
Serum bilirubin, creatinine or INR outside of normal range
Haemoglobin < 7 g/dL and thrombocytes < 75 × 109/L
Liver failure (if cirrhosis, Child-Pugh B or C)
Parallel
Floxuridine
DrugA laparotomy will be performed and a catheter placed in the hepatic artery Connected to a subcutaneous pump. This pump will be percutaneously filled with Floxuridine 6 times in 2 weeks cycles, alternating with heparin-solution. The patients in this arm will also be given GemOX as systemic chemotherapy
Selective Internal Radiation Therapy (SIRT)
Procedure/SurgeryRadioactive Yttrium 90 (Y-90) labeled particles are injected selectively into the feeding arteries of the tumour(s). This allows a high radiation dose in the lesions while limiting systemic side effects.
Overall Survival (OS) at 3 years
The study will assess whether the combination of systemic chemotherapy (current standard) with either SIRT or HAI-FUDR/DEX for patients not amendable to upfront resection may increase the possibility for later resection nad/or prolong survival.
Tumor response
By comparing CT-scans (RECIST 1.1.) we will evaluate the proportions of patients with partial response, proportions of patients with stable disease, duration of stable disease and proportion of patients converted to resectability following downstaging.
Quality of Life by using EORTC QLQ-C30
We will investigate the QuOL regularly by using EORTC QLQ-C30 verified Norwegian edition. We will investigate the QuOL regularly by using EQ-5D-5L verified Norwegian editions where the patients are scoring the variables on a scale from 1 to 4, where higher scores mean a worse outcome.
Quality of Life by using EQ-5D-5L
We will investigate the QuOL regularly by using EQ-5D-5L verified Norwegian editions where the patients are scoring the variables on a scale from 0 to 4, where higher scores means a worse outcome.
Assess the resection rate following downstaging
The study will assess whether the combination of systemic chemotherapy (current standard) with either SIRT or HAI-FUDR/DEX for patients not amenable to upfront resection may increase the possibility for later resection and/or prolong survival.
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