N/A
N=105
HepaSphere™ Microspheres Prospective Registry
Metastatic Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04866290 ↗Enrolled (actual)
105
Serious AEs
1.0%
Results posted
Oct 2022
Primary outcome: Primary: Overall Survival — 19 months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- HepaSphere Microspheres (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Merit Medical Systems, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
19 | — |
| SECONDARY Objective Response Rate (ORR) |
5; 30 | — |
| SECONDARY Best Tumor Response |
5; 30; 25; 23 | — |
| SECONDARY Liver Progression-free Survival |
4.0 | — |
| SECONDARY Time to Progression |
7.0; 6.0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04866290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.