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New treatment option for Intrahepatic Cholangiocarcinoma
Official title HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)
ClinicalTrials.gov ID: NCT06313203
What this study is testing
What is Floxuridine?
Floxuridine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Also referred to as Hepatic Artery Infusion Chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 tumour that is technically not resectable with R0 margins (i.e. where resection will not yield an FLR of sufficient size and function) without...
- Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions
- Recurrent tumour following resection
You likely can't join if
- 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)
- Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis)
- History of peripheral neuropathy
See the full eligibility criteria
- Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection.
- Not amenable for upfront resection. Defined as:
- 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
- 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 GemOx
- 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, as defined in this protocol. Male patients or male patients who have...
- 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)
- Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis)
- History of peripheral neuropathy
- 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.
- Pregnant or lactating women
- Expected life expectancy less than three months.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Oslo, Norway
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.