Combining liver-directed therapy (HAI pump or SIRT) with GemOx chemotherapy for unresectable intrahepatic cholangiocarcinoma (TOMCAT)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, parallel-cohort study assigns patients with unresectable intrahepatic cholangiocarcinoma to one of two liver-directed approaches combined with systemic GemOx chemotherapy: hepatic artery infusion (HAI) with floxuridine and dexamethasone, or selective internal radiation therapy (SIRT). Assignment depends on tumor characteristics, disease stage, and patient ability/preferences, with HAI requiring a surgically implanted pump and frequent fortnightly visits to Oslo and SIRT requiring a specialized work-up and treatment at the same center. Eligible patients have biopsy-confirmed disease largely confined to the liver (or limited resectable porta hepatis nodes), measurable lesions >2 cm, and ECOG performance status 0–1 and must be able to tolerate GemOx. The study measures safety, radiologic response, and the potential to down-stage tumors to allow curative resection.

Why it matters

Who can join: the full rules

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

Where it's running

• Oslo University Hospital
  Oslo, Oslo, Norway Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.