Yttrium Y-90 Radioembolization before Surgery for Tumor Control and Future Liver Remnant Hypertrophy Patients with Colorectal Liver Metastases

Status: active

This phase I trial tests the safety and side effects of yttrium Y-90 radioembolization in controlling tumors in patients with colorectal cancer that has spread to the liver (liver metastases). Yttrium Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply. Researchers want to learn if this procedure can allow for right liver removal (about 8 weeks later) in patients with colorectal liver metastases but do not have enough left-sided liver volume to regenerate (grow back) safely after surgery.

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%, Eastern Cooperative Oncology Group [ECOG] >1)
Portal hypertension and/or cirrhosis
Starting total bilirubin > 1.3 mg/dL (except if patient has Gilbert’s disease)
Carotid endarterectomy (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/uL
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 patients

PRIMARY OBJECTIVE:

I. To examine the safety and feasibility of yttrium Y-90 (Y-90) trans-arterial radioembolization (TARE) directed to the right hemi-liver for induction of left liver future liver remnant (FLR) hypertrophy as part of a planned hepatectomy for patients with colorectal liver metastases (CLM).

SECONDARY OBJECTIVES:

I. To describe changes in liver volume after Y-90 TARE, including:

Ia. The kinetic growth rate (KGR) of the FLR.

Ib. Degree of hypertrophy 6 weeks after TARE.

Ic. Atrophy of targeted right hemi-liver from TARE date to date of surgery.

II. To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE.

III. To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM.

IV. To assess measures of disease control, including:

IVa. Tumor marker trend.

IVb. Response Evaluation Criteria in Solid Tumors (RECIST)/modified (m)RECIST criteria.

IVc. Computed tomography (CT) morphologic response.

IVd. Positron emission tomography (PET) CT response.

V. To describe patient reported outcomes using The MD Anderson Symptom Inventory - Gastrointestinal (MDASI-GI).

VI. To assess FLR liver quality, right-sided surgical adhesions from TARE intraoperatively.

VII. To describe dosimetry of individual liver lesions – using single-photon emission computed tomography (SPECT)/CT, CT, and pathology correlation.

VIII. To describe change in liver function measured by the pre- and post-TARE hepatobiliary iminodiacetic acid (HIDA) SPECT/CT scans and hepatic function blood tests.

OUTLINE:

For patients undergoing single hepatectomy, patients receive Y-90 and undergo TARE over 2-3 hours 8 weeks before surgery. For patients undergoing two-stage hepatectomy, patients receive Y-90 and undergo TARE on the same day as first stage surgery or after discharge from first stage surgery. All patients undergo fludeoxyglucose F-18 (FDG)-PET scan during screening and on study, an arteriogram and technetium Tc 99m lidofenin (99mTc-HIDA) SPECT-CT on study, and CT scans throughout the trial.

After completion of study treatment, patients are followed up for 90 days.

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Yttrium Y-90 Radioembolization before Surgery for Tumor Control and Future Liver Remnant Hypertrophy Patients with Colorectal Liver Metastases

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United States

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Yttrium Y-90 Radioembolization before Surgery for Tumor Control and Future Liver Remnant Hypertrophy Patients with Colorectal Liver Metastases

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