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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: Active NA study of Unresectable Hepatocellular Carcinoma and BCLC Stage B Hepatocellular Carcinoma, sponsored by Sirtex Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ORR uses a localized version of modified Response Evaluation Criteria in Solid Tumors ("localized mRECIST") criteria and best response through 9 months, in patients treated with SIR-Spheres Y-90 resin microspheres.
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 |
What the registry record for NCT04736121 still lists
NCT04736121 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 12 other Unresectable Hepatocellular Carcinoma trials with a reported enrollment target (28% higher).
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 names 20 study sites across 11 states, led by 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
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Where NCT04736121's enrollment target sits among peer trials
100 4th of 12 higher than 9 of 12 other Unresectable Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unresectable Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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