Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04736121 · ClinicalTrials.gov registry record · NA
Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
A NA study of Unresectable Hepatocellular Carcinoma and BCLC Stage B Hepatocellular Carcinoma, sponsored by Sirtex Medical.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT04736121 is a NA study of Unresectable Hepatocellular Carcinoma and BCLC Stage B Hepatocellular Carcinoma that is active but no longer recruiting, run by Sirtex Medical. The registered enrollment target is 100 participants, above the 78-participant average among 12 other Unresectable Hepatocellular Carcinoma trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT04736121, a NA study of Unresectable Hepatocellular Carcinoma and BCLC Stage B Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by Sirtex Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C. SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2, maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver function and good performance status. It is also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR).
Conditions Studied
Interventions
- DEVICE Resin microspheres containing yttrium-90 (Y-90)
Study Locations (20)
California
- University of California Los Angeles - Ronald Reagan Medical Center - Los Angeles
- Providence St. Joseph Hospital - Orange
- University of California Irvine - Orange
Texas
- Clinical Research Institute and Methodist Hospital - Dallas
- University of Texas Health Science Center at Houston - Houston
- UT MD Anderson Cancer Center - Houston
Florida
- Miami Cardiac and Vascular Institute at Baptist Hospital - Miami
- Sarasota Memorial Health Care System - Sarasota
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
North Carolina
- University of North Carolina - Chapel Hill Medical Center - Chapel Hill
- Wake Forest Baptist Health - Winston-Salem
Ohio
- University of Cincinnati Cancer Center CTO - Cincinnati
- The Cleveland Clinic Foundation - Cleveland
Pennsylvania
- Hospital of the University Pennsylvania - Philadelphia
- Allegheny-Singer Research Institute - Pittsburgh
Georgia
- Emory University Hospital Midtown - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2026-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04736121
The ClinicalTrials.gov registry entry for NCT04736121 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 78-participant average among 12 other Unresectable Hepatocellular Carcinoma trials with a reported enrollment target (28% higher). The listed sponsor is Sirtex Medical, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Unresectable Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Resin microspheres containing yttrium-90 (Y-90) is the first listed.
NCT04736121 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT04736121 about?
NCT04736121 is a clinical study titled "Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients". The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C. SIR-Spheres consist of biocompatible resin...
What is the current status of trial NCT04736121?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-05-28. Estimated completion is 2026-09.
What conditions does trial NCT04736121 study?
This clinical trial studies the following conditions: Unresectable Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, BCLC Stage A Hepatocellular Carcinoma.
What interventions are being tested in trial NCT04736121?
The interventions under investigation include: Resin microspheres containing yttrium-90 (Y-90) (DEVICE).
Who is sponsoring clinical trial NCT04736121?
This trial is sponsored by Sirtex Medical, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04736121 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unresectable Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
ACTIVE NOT RECRUITING · NA
-
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
RECRUITING · Phase 2
-
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
RECRUITING · Phase 2
-
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
RECRUITING · Phase 1
-
Atezolizumab+Bevacizumab+SBRT in Unresectable HCC
RECRUITING · Phase 1
-
An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery
RECRUITING
Explore more on PlainTrial
Unresectable Hepatocellular Carcinoma
All registered trials for this condition
BCLC Stage B Hepatocellular Carcinoma
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.