Clinical trial · Interventional
Y90 Radiation Segmentectomy vs SBRT for HCC
Yttrium-90 Radiation Segmentectomy Versus Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Early Stage Hepatocellular Carcinoma (HCC): A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unable to recruit. terminated due to futility
Summary
Brief summary (as posted)
The proposed study is a single site, prospective, randomized pilot study to assess the feasibility of recruitment of patients into a trial evaluating the efficacy and tolerability of selective transarterial Y90 radioembolization (radiation segmentectomy) versus stereotactic body radiation therapy (SBRT) for solitary early stage (≤ 3cm) hepatocellular carcinoma (HCC).
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 (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
| Yttrium-90 Radiation Segmentectomy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Yttrium-90 Radiation Segmentectomy
- interventionNames
- Radiation: Yttrium-90 Radiation Segmentectomy
- type
- ACTIVE_COMPARATOR
- label
- Stereotactic Body Radiation Therapy
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Feasibility of Recruitment (Recruitment Rate)
- timeFrame
- 24 months
- description
- Feasibility of recruitment will be measured by evaluating the proportion of patients enrolled versus those approached for the study after they have been determined to be a candidate.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to provide written informed consent and HIPAA authorization * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥ 18 years at time of informed consent * Solitary HCC (≤3 cm) diagnosed by imaging (LI-RADS 4-5) or histology * Childs-Pugh score ≤ 7 * ECOG performance status 0-1 * Tumor location/characteristics eligible for either SBRT or Y90 therapy as deemed by local tumor board * Adequate organ function defined as: 1. serum bilirubin \< 4.0 mg/dL , 2. albumin \> 2 g/dL Exclusion Criteria: * Any prior locoregional therapy to the target tumor * Any prior radiation therapy to the liver * Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria: i. Has undergone a hysterectomy or bilateral oophorectomy; or ii. Has been naturally amenorrheic for at least 24 consecutive months * Known severe allergic reaction (anaphylaxis) to iodinated contrast * Coagulopathy (platelets \< 50 K/mm3 and/or INR \> 2) not correctable by transfusion * Macrovascular invasion or extrahepatic HCC
References
Publications (0)
Data not yet available