Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases

M.D. Anderson Cancer Center

Status and phase

Enrolling

Phase 1

Conditions

Metastases

Treatments

Drug: Yttrium-90 (Y-90) resin microspheres

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05195710

NCI-2021-13239 (Other Identifier)

2021-0521

Details and patient eligibility

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.

Full description

Primary Objective:

To examine the safety and feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.

Secondary Objectives:

To describe changes in liver volume after Y-90 TARE, including:
- The kinetic growth rate (KGR) of the FLR
- Degree of hypertrophy 6 weeks after TARE
- Atrophy of targeted right hemi-liver from TARE date to date of surgery
To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE
To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM
To assess measures of disease control, including:
- Tumor marker trend
- RECIST/mRECIST criteria
- CT morphologic response
- PET CT response
To describe Patient Reported Outcomes using MDASI-GI
To assess FLR liver quality, right-sided surgical adhesions from TARE intraoperatively
To describe dosimetry of individual liver lesions - using SPECT/CT, CT, and pathology correlation
To describe change in liver function measured by the pre- and post-TARE HIDA SPECT/CT scans and hepatic function blood tests

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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