TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Listed as NCT01349075, this observational or N/A phase trial focuses on Hepatocellular Carcinoma and remains completed. Sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, it has been updated 16 times since 2007, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients present with disease that is not amenable to resection (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates.
The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional therapies for HCC may have several advantages over systemically administered treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than either therapeutic modality alone. TheraSphere may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.
Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients present with disease that is not amenable to resection (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates.
The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional therapies for HCC may have several advantages over systemically administered treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than either therapeutic modality alone. TheraSphere may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.
Status Flow
Change History
16 versions recorded-
Mar 2026 — Present [monthly]
Completed
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Feb 2026 — Present [monthly]
Completed
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Jan 2026 — Present [monthly]
Completed
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May 2025 — Feb 2026 [monthly]
Completed
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Sep 2024 — May 2025 [monthly]
Completed
▶ Show 11 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Completed
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Oct 2021 — Jul 2024 [monthly]
Completed
Status: Recruiting → Completed
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Feb 2021 — Oct 2021 [monthly]
Recruiting
-
Jan 2021 — Feb 2021 [monthly]
Recruiting
-
Mar 2020 — Jan 2021 [monthly]
Recruiting
-
Feb 2019 — Mar 2020 [monthly]
Recruiting
-
Oct 2018 — Feb 2019 [monthly]
Recruiting
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Jun 2018 — Oct 2018 [monthly]
Recruiting
-
Apr 2018 — Jun 2018 [monthly]
Recruiting
Phase: NA → None
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Oct 2017 — Apr 2018 [monthly]
Recruiting NA
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Jan 2017 — Oct 2017 [monthly]
Recruiting NA
First recorded
Oct 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
For direct contact, visit the study record on ClinicalTrials.gov .