Clinical trial · Interventional
LifePearl-Iri Pharmacokinetic Study
Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan
NCT02547480CI-TRIAL-00030529completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.
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 |
|---|---|---|---|
| mCRC | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE with irinotecan loaded LifePearl | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE with irinotecan loaded LifePearl
- description
- 10 patients receiving unilobar treatment: day 1=chemoembolization of first lobe of liver, day 14=chemoembolization of second lobe of liver, day 30=chemoembolization of first lobe of liver, day 44= chemoembolization of second lobe of liver; AND 10 patient receiving bilobar treatment: day 1=chemoembolization of both lobes of the liver, day 30=chemoembolization of both lobes of the liver
- interventionNames
- Device: TACE with irinotecan loaded LifePearl
Primary outcomes (3)
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- 2 days
- description
- Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38
- measure
- Time to reach Cmax (Tmax)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is at least 18 years old * Histologically proven mCRC * At least 1 measurable liver metastasis \> 1 cm (mRECIST) Liver predominant disease ( ≥ 80% of metastatic disease confined to the liver) * No portal vein involvement * Performance status 0 or 1 * Life Expectancy ≥ 3m * Adequate Hematologic function (ANC≥1.5 10\^9/l; PLT≥75 10\^9/l; INR (international normalized ratio) ≤1.3) * Adequate liver and renal function (Total bilirubin ≤2.0 mg/dl; ALBUMINE 2.5g/dl; Serum creatinine ≤2.0 mg/dl; ALT (alanine transaminase),AST (aspartate transaminase) ≤5 times ULN) * Less than 50% liver tumor replacement * Patient has provided written informed consent * Patient is affiliated to social security or equivalent system (France only) Exclusion Criteria: * Eligible for curative treatment (resection/RFA) History of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment) * Previous liver embolization * Contraindication for intra-arterial embolization and local irinotecan administration * Allergy to contrast media * Patient is co-treated with potent CYP3A4/UGT1A1 (cytochrome P450 3A4/uridine diphosphate glucuronosyltransferase 1A1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and St John's Wort * Patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints * In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study * Patient is under judicial protection (France only)
References
Publications (0)
Data not yet available
No reference posted for this study.