N/A
N=29
Impact of Y90 Radiation Segmentectomy on HCC
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03248375 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participants With Local Tumor Response According to mRECIST — 26; 0; 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation Segmentectomy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local Tumor Response According to mRECIST |
26; 0; 0; 3 | — |
| SECONDARY Median Time to Progression (TTP) |
NA | — |
| SECONDARY Cumulative Incidence of Participants With Local Progression |
4; 12 | — |
| SECONDARY Quantifying Dose to Target Lesion |
1004.6 | — |
| SECONDARY Number of Treatment-related Adverse Events |
9; 7; 6; 1; 24 | — |
| SECONDARY Number of Participants With Access Site-related Adverse Events |
1; 4; 24 | — |
| SECONDARY Number of Participants With Treatment-related Laboratory Adverse Events |
13; 3; 6; 4; 4; 4 | — |
Summary
The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years, regardless of race or gender
- Hepatocellular Carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to AASLD for cirrhotic patients
- Child-Pugh class A or B7 without ascites
- Single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct
- No prior locoregional treatment or external beam therapy of current HCC (recurrent HCC after resection may be included)
- No confirmed extrahepatic metastases
- No evidence of macrovascular invasion
- ECOG 0
- Albumin > 3.0 g/dL
- PLT ≥ 40 x103/μL
- WBC ≥ 1.5 x103/μL
- AST/ALT ≤ 5 times the upper limit of normal (U/L)
- Creatinine ≤ 2.0 mg /dL
- No indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation)
- No contraindication to angiography or selective visceral catheterization
- No history of severe allergy or intolerance to contrast agents, narcotics, sedatives.
- Negative serum pregnancy test
- Signed informed consent form
Exclusion Criteria
- Not meeting the inclusion criteria
Data sourced from ClinicalTrials.gov (NCT03248375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.