Using Y-90 radioembolization to improve liver function before surgery for colorectal cancer spread to the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.