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| Name | Class |
|---|---|
| Federation Francophone de Cancerologie Digestive | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE with irinotecan loaded LifePearl | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE with irinotecan loaded LifePearl | Device | Arterial embolization will be performed through lobar infusion and using a microcatheter. LifePearl microspheres of 200 µm will be used as preferred beads. They will be loaded with the appropriate dose of irinotecan hydrochloride injectable solution, mixed with the contrast media and distributed to the targeted lobe. The targeted dose is 100 mg of irinotecan per lobe treated, meaning that when treated unilobarly at baseline the total dose received will be 100 mg ( all in one lobe) and in during bilobar treatment, 200 mg in both lobes. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38 | 2 days |
| Time to reach Cmax (Tmax) | Tmax will be estimated directly from concentration-time data | 2 days |
| Area Under the Curve (AUC) | The trapezoidal rule will be used to calculate the area under the curve over 24 hours | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment | 1 month | |
| Overall Survival | 12 months | |
| Progression-Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Prenen, MD | Universitair Ziekenhuis Leuven | Principal Investigator |
| Philippe Pereira, MD | SLK Kliniken Heilbronn GmbH | Principal Investigator |
| Julien Taieb, MD | Hôpital Georges Pompidou Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KUL | Leuven | Belgium | ||||
| SLK-Kliniken Heilbronn GmbH |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 12 months |
| Response rate | Response rate (mRECIST criteria) 3 months after the first treatment | 3 months |
| Technical success - treatment delivery | Ability to deliver ≥75% of the planned dose during the first chemoembolization | 1 day |
| Technical success - total dose delivered | Sum of all doses delivered during the course of the study | 6 weeks |
| Heilbronn |
| Germany |
| Klinikum Bogenhausen, Städt. Klinikum München GmbH | Munich | Germany |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |