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| ID | Type | Description | Link |
|---|---|---|---|
| ZonMW | Other Grant/Funding Number | PTO 2017 - 40-41200-98-9286 |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Health Holland | OTHER |
| Quirem Medical B.V. | INDUSTRY |
| Medtronic |
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In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.
RFA + adjuvant radioembolsation with Quirem Spheres
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA + radioembolization | Other | Quirem Medical Holmium-166 radioembolization microspheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quirem Medical Holmium-166 radioembolization microspheres | Device | radioembolisation as adjuvant treatment to RFA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-finding | Treatment area dose that will result in delivery of a radiation absorbed dose of ≥ 120Gy to the target area in at least 90% of patients. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0 | 1 year |
| Local tumor recurrence | Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38329507 | Derived | Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach S, van Delden OM, Dibbets-Schneider P, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular and Cholangiocarcinoma Group. Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial). Eur J Nucl Med Mol Imaging. 2024 Jun;51(7):2085-2097. doi: 10.1007/s00259-024-06630-z. Epub 2024 Feb 8. | |
| 35618860 |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| INDUSTRY |
| Maag Lever Darm Stichting | OTHER |
single-arm, interventional, dose escalation study
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| 6 months and 12 months |
| Time to progression | time until disease progresses | 1 year |
| Progression-free survival | Kaplan-Meier analysis of progression free survival | 1 year |
| Quality of Life | Quality of Life will be assessed by means of the EORTC QLQ HCC-18 questionnaire | Throughout the first year after treatment. |
| Quality of Life | Quality of Life will be assessed by means of the C-30 questionnaire | Throughout the first year after treatment. |
| Derived |
| Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach ASLP, van Delden OM, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular Cholangiocarcinoma Group. Study Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial). Cardiovasc Intervent Radiol. 2022 Aug;45(8):1057-1063. doi: 10.1007/s00270-022-03162-7. Epub 2022 May 26. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |