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

NCT05195710 | Recruiting Phase 1 DMC

• 2 other identifiers: 2021-0521NCI-2021-13239
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Study Arms (1)

Yttrium-90

EXPERIMENTAL

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.

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

Interventions

Yttrium-90 (Y-90) resin microspheres DRUG

Given by scan

Yttrium-90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sirtex Medical: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Yttrium-90

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ching-Wei Tzeng, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Wei Tzeng, MD

CONTACT

(713) 792-0386; cdtzeng@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 19, 2022
• Study Start: November 16, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)