Clinical trial · Observational
Irinotecan Drug-eluting Bead Liver Embolisation Registry
Irinotecan Loaded Drug-eluting Beads (DEBIRI) for the Treatment of Liver Metastases From Colorectal Cancer - An Observational Study and Patient Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose: The purpose of this study is: to assess and define the current practice of the delivery of irinotecan loaded drug eluting beads in the treatment of liver metastases from colorectal cancer; to correlate how the delivery of this drug compares to worldwide/European guidelines, and to determine which individual variations in delivery may be associated with an increased complication profile or better outcome. The aim of the study is to: 1. Prospectively evaluate the number of centres providing DEBIRI 2. To determine the number of patients being treated nationally per year 3. To evaluate individual variations in practice with respect to number of treatments, method of pain control, side effect profile, and complication profile. 4. To collect patient specific data subsets to allow correlation and causal associations between these individual variations, and relate these to efficacy and survival during the study period.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan Drug-Eluting-Bead Trans Arterial ChemoEmbolisation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to Hepatic Progression (TtHP)
- timeFrame
- 2 years after treatment
- description
- Progression as measured by RECIST 1.1 criteria up to 2 years after treatment
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- 2 years after treatment
- description
- Survival, defined as any time between start of treatment and death from any cause.
- measure
- Adverse events
- timeFrame
- 4 months after treatment
- description
- An adverse event (AE) is defined as any untoward or unfavourable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with the patient's participation in the research. It includes all adverse events regardless of seriousness or relatedness. A serious adverse event (SAE) is defined as an adverse event that: a. Results in death, b. Led to a serious deterioration in health that either: Results in a life-threatening illness or injury; results in a permanent impairment of a body structure or a body function; requires in-patient hospitalization or prolongation of existing hospitalization; results in medical or surgical intervention to prevent life threatening illness or injury; results in a persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or, c. Led to fetal distress, foetal death or a congenital abnormality or birth defect
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Any race or sex * Age 18-80. * Histological diagnosis of Colorectal malignancy. * Histological or radiological evidence of liver metastases from Colorectal Primary. * Not suitable for surgical resection or ablation with curative intent. * Metastatic liver burden occupying less than 50% of liver volume * Liver dominant disease (defined as 80% or more of the overall whole body tumour burden confined to the liver). * At least 1 measurable liver metastasis measuring over 1cm in size (RECIST 1.1 criteria to be applied). * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. ECOG 2 may occasionally be permissible on an individual patient by patient basis in line with local guidelines. * Life expectancy 3+ months. * Lack of pregnancy with ongoing use of acceptable contraceptive(in premenopausal women. * Patent main portal vein. * Adequate haematologic function as evidenced by: Haemoglobin of at least 8g/dl, platelets of at least 50 x 109/l, and International Normalised Ratio (INR) of under 1.5. * Adequate liver function as evidence by a bilirubin level of less than twice the upper limit of normal. * Deemed to be a suitable patient for DEBIRI treatment by MDT consensus. * Consenting to inclusion in registry. Exclusion Criteria: * Any patient not fitting inclusion criteria. * Previous or concurrent non-colorectal malignancy. * No contraindication to Irinotecan administration. * Uncorrectable clotting abnormality * Documented allergy to contrast media that cannot be managed with standard care(steroids and antihistamines) * Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up or from complying with protocol procedures
References
Publications (0)
Data not yet available