Clinical trial · Observational
Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC With Y90 SIR-Spheres
Evaluating the Effects of Segmental/Super Selective Treatment Utilizing Flex-dosing in Treating Unresectable HCC With Y90 SIR-Spheres
NCT04903548CI-TRIAL-00106358completedClinicalTrials.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 overall objective of this research study is to evaluate outcomes associated with flex-dosing in Y90 SIR-Sphere administration in a prospective cohort of unresectable HCC patients eligible for segmental/super selective treatment at Methodist Dallas Medical Center (MDMC).
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIRT with Y-90 resin microspheres | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (14)
- measure
- Patient demographics
- timeFrame
- May 2020 - 2022
- description
- Patient demographics
- measure
- Volumes for liver to be treated
- timeFrame
- May 2020 - 2022
- description
- liver volume prior to treatment
- measure
- Lobe/segment to be treated
- timeFrame
- May 2020 - 2022
- description
- treatment location
- measure
- Tumor volume
- timeFrame
- May 2020 - 2022
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * All patients diagnosed with unresectable HCC in two of fewer hepatic segments at MDMC who undergo at least one SIRT procedure with Y-90 resin microspheres (SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia) will be included in data capture. HCC is considered unresectable if it is multifocal or bilobar, or if the patient has malignant portal vein thrombosis, portal hypertension, or decompensated liver disease (Child-Pugh B or C). * Eligible cases for inclusion are those that would have undergone Y-90 resin SIRT and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; platelets \>60,000; creatinine \<2 mg/dL; bilirubin \<2 mg/dL; and international normalized ratio (INR) \<1.2. Exclusion Criteria: * Subjects that do not meet the inclusion criteria * Patients are not eligible for SIRT if they had any extrahepatic disease; contraindication to hepatic artery catheterization such as vascular abnormalities, bleeding diathesis, allergy to contrast dye, concurrent malignancy, refractory ascites, previous external beam radiation, or evidence of any uncorrectable flow to the gastrointestinal tract; or greater than 30 Gy of radiation estimated to be delivered to the lung based on angiography or Tc-99 microaggregated albumin scan (shunt fraction of 20% or greater).
References
Publications (0)
Data not yet available
No reference posted for this study.