Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases

Launched by M.D. ANDERSON CANCER CENTER · Jan 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Y-90 radioembolization, which is designed to help control tumors in the liver for patients with colorectal liver metastases (CLM). The goal is to see if this treatment can safely reduce tumors on the right side of the liver and help the left side grow larger, making it possible for patients to undergo surgery to remove the tumors later. The trial is currently looking for participants who have liver tumors that are difficult to operate on due to the size of their liver and have already received chemotherapy.

To be eligible, participants should be between the ages of 65 and 74, have specific types of liver tumors that are still considered treatable, and be in good enough health to undergo surgery. Those interested can expect to receive the Y-90 treatment, followed by careful monitoring to see how well it works before any planned liver surgery. It's important to note that not everyone will qualify for the trial, as certain medical conditions and health factors will be considered. If you're interested or think you might qualify, talking to your doctor would be a great first step.

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Eligibility criteria

• Inclusion Criteria:
• • 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
• • Medically and physically operable as determined by the surgeon
• Exclusion Criteria:
• • 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
• • Starting total bilirubin \>1.3 mg/dL (except if patient has Gilbert's Disease)
• • CEA \>200 after 4 cycles of chemotherapy upon restaging visit
• • Clinical progression of disease on imaging and/or tumor marker after 4 cycles of chemotherapy that is clinically judged by surgical oncology and medical oncology to preclude surgical resection
• • Platelet count \<100,000/µL
• • Albumin \<3.5 g/dl
• • Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy)
• • Pregnant or breast-feeding patient
• • Other medical or clinical contraindications to liver surgery
• • Non-English-speaking participants