Clinical trial · Interventional
Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry
Selective Internal Radiation Therapy for Hepatocellular Carcinomas With Yttrium-90 Loaded Microspheres: Optimized Dosimetry Versus Standard Dosimetry
NCT02582034CI-TRIAL-00036849completedPhase 2ClinicalTrials.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 purpose of this study is to determine whether a treatment with Therasphere which is optimized is more efficient compared to a standard treatment for patients suffering from hepatocellular carcinomas.
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 |
|---|---|---|---|
| Adenoma, Liver Cell | Hepatocellular Adenoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optimized Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| Standard Internal Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard dosimetry
- description
- Standard Internal Radiation Therapy : Dose of radiation delivered to the tumoral volume is fixed : 120 Gray (GY)
- interventionNames
- Radiation: Standard Internal Radiation Therapy
- type
- EXPERIMENTAL
- label
- Optimized dosimetry
- description
- Optimized Internal Radiation Therapy : Dose of radiation absorbed by the tumor is \> 205 GY, if possible 250 or 300 Gy.
- interventionNames
- Radiation: Optimized Internal Radiation Therapy
Primary outcomes (1)
- measure
- The primary endpoint is to compare the response rate of the treated lesion at the first radioembolization, evaluated using European Association for the Study of the Liver (EASL) criteria of yttrium-90 marked glass microspheres SIRT
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18, * Written free and informed consent, * Histologically demonstrated Hepatocellular Carcinoma (HCC), not a candidate for surgery or local ablative treatment (radio frequency, etc.) * Barcelona Clinic Liver Cancer (BCLC) classification A, B or C, * At least one lesion ≥ 7 cm, * Hepatic reserve (hepatic parenchyma not treated) after the first SIRT ≥ 30%, * Unilateral involvement, minimal bilateral involvement allowed only with a hepatic reserve ≥ 30% after SIRT * Child A classification only, or B but with bilirubinemia \<35 micromol/L, * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, * Patients whose biological parameters meet the following criteria: * Hemoglobin ≥ 8.5 g/dL, * Granulocytes ≥ 1500/mm3, * Platelets ≥ 50,000/mm3, * Bilirubinemia \<35 micromol per liter, * Transaminases ≤ five times the upper limit of normal, * Creatininemia ≤ 1.5 times the normal upper limit, * Expected survival over 12 weeks, * Negative pregnancy test for women of childbearing age, * If sorafenib has been taken the diagnostic angiogram must follow it by at least four weeks after its stop. Exclusion Criteria: * HCC operable or accessible to a local ablative treatment (radio frequency), * Hepatectomy history unless a segmental treatment is considered, with a hepatic reserve ≥ 30% after SIRT, * Prior treatment with sorafenib unless stopped at least four weeks earlier, * History of chemo-embolization of the principal lesion, except in case of nodular residual lesion measuring at least 7 cm or in case of progression after initial response, * Bilateral disease requiring a whole liver injection or with a hepatic reserve \< 30% after SIRT * Treatment of another cancer less than one year earlier, * Extra-hepatic metastases other than adenopathies of the hilum smaller than 2 cm, * \>70% tumor invasion of the liver, * Bilirubinemia ≥ 35 µmol/L, * A Severe underlying biliary pathology: * Bile duct anomaly (stent, dilation) Cirrhosis of biliary origin, * Women of childbearing age without contraception * Pregnant or nursing women
References
Publications (2)
- DERIVEDGarin E, Tselikas L, Guiu B, Chalaye J, Rolland Y, de Baere T, Assenat E, Tacher V, Palard X, Deandreis D, Mariano-Goulart D, Amaddeo G, Boudjema K, Hollebecque A, Meerun MA, Regnault H, Vibert E, Campillo-Gimenez B, Edeline J. Long-Term Overall Survival After Selective Internal Radiation Therapy for Locally Advanced Hepatocellular Carcinomas: Updated Analysis of DOSISPHERE-01 Trial. J Nucl Med. 2024 Feb 1;65(2):264-269. doi: 10.2967/jnumed.123.266211. PMID 38212068
- DERIVEDGarin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7. PMID 33166497