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Trans-arterial treatment of patients with intra-hepatic cholangiocarcinoma not amenable to resection (TOMCAT)
EU CTIS ID: 2023-504433-50-00
What this study is testing
Evaluate the overall survival (OS) of HAI-FUDR/DEX or SIRT in combination with systemic GemOx
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection.
- Not amenable for upfront resection. Defined as: a) 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. b) Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions. c) Recurrent tumor following resection. d)Radiologically or cytology-proven malignant regional lymph nodes
- Disease confined to the liver or associated with limited, resectable porta hepatis lymph node metastases.
- Radiologically measurable disease with at least one lesion > 2 cm in greatest diameter.
- Physical performance score WHO/ECOG stage 0/1
- Age > 18 years
You likely can't join if
- Any non-liver malignant deposit (except for resectable, hilar lymph nodes).
- Pregnant or lactating women
- Life expectancy less than three months
- Externalized biliary duct drain (PTC/PTBD). Stents without externalized component are accepted, also trans-papillary ones
- Inability to comply with study routines or follow-up procedures
- Inability to read and comprehend Norwegian
See the full eligibility criteria
Who can join
- Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection.
- Not amenable for upfront resection. Defined as: a) 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. b) Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions. c) Recurrent tumor following resection. d)Radiologically or cytology-proven malignant regional lymph nodes
- Disease confined to the liver or associated with limited, resectable porta hepatis lymph node metastases.
- Radiologically measurable disease with at least one lesion > 2 cm in greatest diameter.
- Physical performance score WHO/ECOG stage 0/1
- Age > 18 years
- Assumed ability to tolerate at least one full cycle of systemic chemotherapy (unless no relevant regimen ramains)
- For eligibility to HAI-FUDR/DEX treatment, patients must be willing and able to go to Oslo every fortnight.
- Women of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study depending on product administered (see section 6.1). 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 depending on product administered (see section 6.1). 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
What rules you out
- Any non-liver malignant deposit (except for resectable, hilar lymph nodes).
- Pregnant or lactating women
- Life expectancy less than three months
- Externalized biliary duct drain (PTC/PTBD). Stents without externalized component are accepted, also trans-papillary ones
- Inability to comply with study routines or follow-up procedures
- Inability to read and comprehend Norwegian
- Arterial anatomy unsuited for SIRT or HAI, respectively
- Any reason why, in the view of the investigators, the patient should not be included
- Ingrowth into the gallbladder precluding cholecystectomy or fenestration sufficient to prevent any subsequent cholecystitis or necrosis will exclude the patient from HAI, but not from SIRT
- Ingrowth into any adjacent organ including the diaphragm
- Serum bilirubin, creatinine or INR outside of normal range
- Haemoglobin < 7 g/dL and thrombocytes < 75 × 10^9/L
- Liver failure (if cirrhosis, Child-Pugh B or C for HAI-pump, and above B7 for SIRT)
- Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis) will exclude HAI-pump but not SIRT
- More than 70 % of liver consisting of tumour
- History of other malignancy past three years except localized/early stage cancer that has been adequately resected
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.