NCT06313203 HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 39 participants in total. It began in 2024-02-13 with a primary completion date of 2031-01.

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 1. Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection. 2. Not amenable for upfront resection. Defined as: 1. 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. 2. Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions 3. Recurrent tumour following resection 4. Radiologically or cytology-proven malignant regional lymph nodes 3. Disease confined to the liver or associated with limited, resectable porta hepatis lymph node metastases 4. Radiologically measurable disease with at least one lesion \> 2 cm in greatest diameter 5. Physical performance score WHO/ECOG stage 0/1 6. Age \> 18 years 7. Assumed ability to tolerate at least one full cycle of GemOx 8. For eligibility to HAI-FUDR/DEX treatment, patients must be willing and able to go to Oslo every fortnight 9. Women of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Male patients or male patients who have female partners of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Exclusion Criteria: 1. Any non-liver malignant deposit (except for resectable, hilar lymph nodes) 2. Serum bilirubin, creatinine or INR outside of normal range 3. Haemoglobin \< 7 g/dL and thrombocytes \< 75 × 109/L 4. Liver failure (if cirrhosis, Child-Pugh B or C) 5. Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis) 6. History of peripheral neuropathy 7. More than 70 % of liver consisting of tumour 8. History of other malignancy past three years except localized/early stage cancer that has been adequately resected. 9. Pregnant or lactating women 10. Expected life expectancy less than three months. 11. Inability to comply with study routines or follow-up procedures 12. Inability to read and comprehend Norwegian 13. Arterial anatomy unsuited for SIRT or HAI, respectively 14. Any reason why, in the view of the investigators, the patient should not be included

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