Clinical trial · Interventional
Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
NCT01686880CI-TRIAL-00018420TRYPHONterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor recruitment and an unexpected low treatment rate
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sirsphere trans-arterial radioembolization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative aTARE
- description
- The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery
- interventionNames
- Device: Sirsphere trans-arterial radioembolization
Primary outcomes (1)
- measure
- Peri-operative morbidity
- timeFrame
- 3 months after surgery
- description
- peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)
Secondary outcomes (5)
- measure
- Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy. * HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy. * Borderline resectable disease eligible for surgical resection or radiofrequency destruction. * No extra-hepatic dissemination. * ECOG Performance status \< 2. * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Signed written informed consent (approved by an Independent Ethics Committee) obtained prior to any study specific baseline procedures. Exclusion Criteria: * Decompensated cirrhosis (Child Pugh B, C). * Extra-hepatic tumour spread. * Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin. * Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence). * Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, …). * Previous trans-arterial radioembolization (TARE). * History of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials. * Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months. * Major surgery within four weeks. * Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Uncontrolled Diabetes.
References
Publications (1)
- DERIVEDLemaire M, Lucidi V, Bouazza F, Katsanos G, Vanderlinden B, Levillain H, Delatte P, Garcia CA, Vouche M, Galdon MG, Demetter P, Deleporte A, Hendlisz A, Flamen P, Donckier V. Selective internal radiation therapy (SIRT) before partial hepatectomy or radiofrequency destruction for treatment of hepatocellular carcinoma in cirrhotic patients: a feasibility and safety pilot study. HPB (Oxford). 2018 Jul;20(7):641-648. doi: 10.1016/j.hpb.2018.01.006. Epub 2018 Feb 24. PMID 29486918