Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT06313203
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06313203
Study Brief:
Protocol Section:
NCT06313203