A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.
Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team
Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart
Received at least four cycles (or two months) of chemotherapy
Willing, able and mentally competent to provide written informed consent
Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy (surgery, radiation, or ablation) as determined by the patient's medical oncologist and surgical oncologist
Projected sFLR before Y-90 of <20% (starting with sFLR that is unrealistic for improvement to ≥30%)
Performance status limitations (Karnofsky <80%, ECOG >1)
Portal hypertension and/or cirrhosis
Single group
Yttrium-90 (Y-90) resin microspheres
DrugGiven by scan
The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
The evaluation of using the safety of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
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M.D. Anderson Cancer Center
Lead sponsor
Sirtex Medical
Collaborator
