Clinical trial · Observational
HepaSphere™ Microspheres Prospective Registry
Prospective Registry of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver With HepaSphere™ Microspheres Loaded With Irinotecan
- 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)
HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015. The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HepaSphere Microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 24 months
- description
- Median overall survival of subjects treated with HepaSphere Microspheres loaded with irinotecan. Analysis will be performed when all subjects enrolled have been followed for survival for two years (24 months), are considered lost to follow up, or have died, whichever comes first
Secondary outcomes (4)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 24 months
- description
- Determined by the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) when all subjects enrolled have been followed for survival for 2 years (from date of 1st TACE), are considered lost to follow up, or have died, whichever comes first. Per mRECIST (target lesions assessed by MRI): Complete Response (CR), at least \>=30% decrease in the sum of diameters of all viable target lesions, Partial Response (PR), at least a \>=30% decrease in the sum of diameters of all viable target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Overall Response (OR) = CR + PR. ORR is calculated as= (no. of patients with CR + the no. of patients with PR) / N. (N= No of participants analyzed)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically or radiologically confirmed colorectal cancer metastases to the liver * Patient is able to have either CT or MRI imaging * Hepatic tumor burden ≥50% of total tumor burden * Hepatic tumor burden ≤50% of total liver volume * Not suitable for treatment by resection or percutaneous ablation at time of TACE treatment * Life expectancy ≥ 3 months * WHO performance status ≤ 2 Exclusion Criteria: * Previous treatment with any form of hepatic transarterial embolization * Total bilirubin ≥ 3.0 mg/dL * Any contraindication for irinotecan administration * Partial or complete thrombosis of the main portal vein * Cardiovascular or respiratory failure * Any other condition deemed exclusionary by the Investigator
References
Publications (0)
Data not yet available