Recruiting
Phase 1

Y-90 Radioembolization

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05195710

Conditions

Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Yttrium-90 (Y-90) resin microspheres

Study Details

Brief summary:

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

Metastases

Study ID

NCT05195710

Start date

Nov 16, 2022

Status verified date

May, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Yttrium-90

Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows.

Interventions

Yttrium-90 (Y-90) resin microspheres

Given by scan

Primary outcome measure

  • The evaluation from using the 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. [ Time Frame: through study completion, an average of 1 year ]
  • The evaluation of using the safety 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. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Ching-Wei Tzeng, MD

(713) 792-0386cdtzeng@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Ching-Wei David Tzeng, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-26.