NL-OMON50334
Completed
Phase 3
A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC). - TheraSphere® in Unresectable Hepatocellular Carcinoma (HCC). STOP-HCC
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- hepatocellular carcinoma
- Sponsor
- Biocompatibles UK Ltd.
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Must have signed informed consent prior to any study\-related evaluation
- •2\. Must be male or female patients over 18 years of age
- •3\. Must have unresectable HCC confirmed by histology or by non\-invasive AASLD10
- •4\. Must have measurable disease defined as at least one uni\-dimensional
- •measurable lesion by CT
- •or MRI (according to RECIST 1\.1\)
- •5\. Must have a Child Pugh score \<\= 7 points
- •6\. Must have an ECOG Performance Status score of \<\= 1
- •7\. Must have a Life expectancy of 12 weeks or more
- •8\. Must have be eligible to receive SOC sorafenib
Exclusion Criteria
- •16\. Must not have main PVT (branch portal vein thrombosis is permissible).
- •17\. Must not be eligible for curative treatment (e.g ablation or
- •transplantation)
- •18\. Must not have a history of previous or concurrent cancer other than HCC
- •unless treated curatively 5 or more years prior to entry
- •19\. Must not have confirmed presence of extra\-hepatic disease with the
- •exception of lung nodules
- •and mesenteric or portal lymph nodes \<\= 2\.0 cm each
- •20\. Must not be at risk of hepatic or renal failure
- •21\. Must not have tumor replacement \>70% of total liver volume based on visual
Outcomes
Primary Outcomes
Not specified
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