NCT05195710RecruitingPhase 1
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 Nov 2021
- Start date
- 16 Nov 2022
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT05195710
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 16 Nov 2022 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CEA \>200 after 4 cycles of chemotherapy upon restaging visit
- Other medical or clinical contraindications to liver surgery
Other illness
- 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
- Portal hypertension and/or cirrhosis
- 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
- Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy)
Lab values
- Starting total bilirubin \>1.3 mg/dL (except if patient has Gilbert's Disease)
- Platelet count \<100,000/µL
- Albumin \<3.5 g/dl
Other
- Projected sFLR before Y-90 of \<20% (starting with sFLR that is unrealistic for improvement to ≥30%)
- Performance status limitations (Karnofsky \<80%, ECOG \>1)
- Pregnant or breast-feeding patient
- Non-English-speaking participants
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.