Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Pat… (NCT05195710) | Clinical Trial Compass
RecruitingPhase 1
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
United States50 participantsStarted 2022-11-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: through study completion, an average of 1 year
2
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.
Timeframe: through study completion, an average of 1 year