Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer
- Conditions
- Carcinoma, HepatocellularNeoplasm Metastasis
- Registration Number
- NCT00701168
- Lead Sponsor
- Leo W. Jenkins Cancer Center
- Brief Summary
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
- The cancer must be unresectable with limited established treatment options
- ECOG Performance Status Score 0-2
- Age 19 years or older
- Able to comprehend and provide written informed consent
Exclusion Criteria
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count ≤ 1,500/ul
- Platelet count ≤ 75,000/ul
- Serum creatinine > 2.0 mg/dl
- Serum bilirubin ≥ 2.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization:
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
- Bleeding, diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization
- Substantial venous shunt away from the liver
- Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
- Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
- Significant extrahepatic disease representing an imminent life- threatening situation outcome
- Severe liver dysfunction or pulmonary insufficiency
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Pregnant women may not participate
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Therasphere® Y-90 microsphere efficacy in hepatocellular carcinoma and metastatic liver tumors?
How does Therasphere® radioembolization compare to sorafenib or lenvatinib in treating unresectable HCC and chemotherapy-resistant liver metastases?
Which biomarkers (e.g., AFP, VEGF) correlate with response to Therasphere® in patients with advanced hepatocellular or metastatic liver cancer?
What are the long-term adverse events associated with Therasphere® HDE use in chemotherapy-refractory liver tumor patients?
Are there combination therapies (e.g., immunotherapy, targeted agents) that enhance Therasphere® outcomes for unresectable liver cancers?
Trial Locations
- Locations (1)
Leo W Jenkins Cancer Center at East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States