Actively Recruiting
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
Led by M.D. Anderson Cancer Center · Updated on 2025-11-10
50
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Sirtex Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Borderline resectable or unresectable colorectal liver metastases with potential curative intent as determined by the surgeon and multidisciplinary team
- Anticipated standardized future liver remnant (sFLR) requiring right portal vein embolization to increase sFLR before planned single or two-stage hepatectomy
- 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
You will not qualify if you...
- Extrahepatic disease that prevents curative intent treatment sequencing (treatable primary tumor and lung metastases allowed with planned local therapy)
- Projected sFLR before Y-90 less than 20% (unrealistic for improvement to 30% or more)
- Performance status with Karnofsky less than 80% or ECOG greater than 1
- Portal hypertension and/or cirrhosis
- Starting total bilirubin greater than 1.3 mg/dL (except Gilbert's Disease)
- CEA greater than 200 after 4 cycles of chemotherapy at restaging
- Clinical disease progression on imaging or tumor markers after 4 chemotherapy cycles precluding surgery
- Platelet count below 100,000/μL
- Albumin less than 3.5 g/dL
- Symptomatic primary colon or rectal cancer without existing proximal diverting ostomy
- Pregnant or breastfeeding patient
- Other medical or clinical contraindications to liver surgery
- Non-English-speaking participants
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Ching-Wei Tzeng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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