Using Y-90 radioembolization to improve liver function before surgery for colorectal cancer spread to the liver
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
PHASE1 · M.D. Anderson Cancer Center · NCT05195710
This study is testing if a treatment called Y-90 radioembolization can help patients with colorectal cancer spread to the liver grow enough healthy liver tissue to safely undergo surgery.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05195710 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the safety and feasibility of Y-90 radioembolization (TARE) directed at the right side of the liver to induce hypertrophy of the left liver lobe in patients with colorectal liver metastases (CLM) who have insufficient future liver remnant (FLR) for surgery. The study aims to assess changes in liver volume, the growth rate of the FLR, and the effectiveness of the treatment in enabling curative-intent surgery. Additional objectives include monitoring disease control through various imaging and tumor marker assessments, as well as evaluating patient-reported outcomes and liver function changes. The study is designed to provide insights into the potential benefits of Y-90 TARE in preparing patients for liver surgery.
Who should consider this trial
Good fit: Ideal candidates include patients with borderline resectable colorectal liver metastases who have insufficient liver volume for surgery and have received prior chemotherapy.
Not a fit: Patients with extrahepatic disease that prevents curative treatment sequencing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes for patients with colorectal liver metastases by improving liver function and enabling more patients to undergo curative surgery.
How similar studies have performed: Other studies have shown promising results with Y-90 radioembolization for liver tumors, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Ching-Wei Tzeng, MD — M.D. Anderson Cancer Center
- Study coordinator: Ching-Wei Tzeng, MD
- Email: cdtzeng@mdanderson.org
- Phone: (713) 792-0386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastases