Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma

NCT07110233 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: RLOKKEN-A
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.

Conditions

Hepatocellular Cancer; Hepatocellular Carcinoma Non-resectable; Unresectable Hepatocellular Carcinoma; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) by mRECIST

  The objective response rate (ORR) after radiation segmentectomy in participants will be evaluated using a modified Response Evaluation Criteria in Solid Tumors (mRECIST) based on the best tumor response where Complete Response (CR) is defined as the disappearance of any intratumoral arterial enhancement in all target lesions, Partial Response (PR) is defined as a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions, Stable Disease (SD) is defined as any cases that do not qualify for either partial response or progressive disease, and Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started.

  Up to 6 months

• Percentage of participants with treatment-related adverse events

  The percentage of participants with grade 3 or greater, treatment-related adverse events as classified by NCI Common Terminology Criteria for Adverse Events (CTCAE) will be reported.

  Up to 6 months

Secondary Outcomes (8)

• Median time from TheraSphere administration to transplant

  Up to 3 years

• Median time to disease progression

  Up to 3 years

• Changes in mean Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) survey results over time

  Up to 6 months

• Changes in mean EuroQol five-dimensional Questionnaire (EQ-5D) survey results over time

  Up to 6 months

• Best observed tumor response by mRECIST.

  Up to 1 year

Study Arms (2)

Group 1. TheraSphere® Yttrium-90 microspheres

EXPERIMENTAL

Participants with a single tumor measuring 2-5 cm will receive one dose of TheraSphere® \>250 Gy, and ideally \> 400 Gy at the treating physician's discretion. Participants will be monitored for safety and complete quality of life questionnaires.

Device: TheraSphere® Yttrium-90 microspheres; Other: Health Related Quality of Life Questionnaires (HRQOL)

Group 2. TheraSphere® Yttrium-90 microspheres

EXPERIMENTAL

Participants with 2-3 tumors ≤ 3 cm in diameter (T2 disease) will receive one dose of TheraSphere® \>250 Gy, and ideally \> 400 Gy at the treating physician's discretion. Participants will be monitored for safety and complete quality of life questionnaires.

Device: TheraSphere® Yttrium-90 microspheres; Other: Health Related Quality of Life Questionnaires (HRQOL)

Interventions

TheraSphere® Yttrium-90 microspheres DEVICE

Administered intra-arterially

Also known as: TheraSphere®, Yttrium-90 microspheres, Microspheres Radionuclide

Group 1. TheraSphere® Yttrium-90 microspheres; Group 2. TheraSphere® Yttrium-90 microspheres

Health Related Quality of Life Questionnaires (HRQOL) OTHER

Surveys administered

Also known as: HRQOL Questionnaires

Group 1. TheraSphere® Yttrium-90 microspheres; Group 2. TheraSphere® Yttrium-90 microspheres

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or imaging-confirmed confirmed HCC.
• Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter.
• No prior therapy to target tumor(s).
• Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment.
• Age ≥22 years.
• Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1.
• Demonstrated adequate organ function as defined below:
• Total bilirubin ≤3.0 mg/dL, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.
• aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤5 X institutional upper limit of normal.
• alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤5 X institutional upper limit of normal.
• Creatinine Glomerular filtration rate (GFR) \> 30 ml/min.
• Child-Pugh score ≤ B7
• Albumin-bilirubin (ALBI) score 1-2
• Participants who have received systemic therapy for HCC will be excluded from the trial.
• Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

• Macrovascular tumor invasion or infiltrative appearance of hepatocellular carcinoma.
• History of severe allergy to iodinated contrast agents despite appropriate premedication.
• Is currently receiving any other anti-cancer agents and any previous therapy with a device that uses Y90 as the radioisotope.
• Symptomatic heart failure or severe valvular insufficiency.
• Symptomatic pulmonary hypertension or lung disease.
• Symptomatic ascites.
• Severe uncontrolled coagulopathy International Normalized Ratio (INR) ≥ 3.0 or Platelet ≤ 20,000.
• Main vein thrombosis (portal vein, both bland and tumor thrombus). Note: Less than lobar portal vein thrombosis is allowable only if the thrombus is bland.
• Pregnant women are excluded from this study because TheraSphere emits radiation with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSphere, breastfeeding should be discontinued if the mother is treated with TheraSphere.
• Lung-shunt fraction (LSF) resulting in anticipated lung dose of \>30 Gray (Gy).
• History of sphincterotomy, biliary-enteric anastomosis, or other biliary tract instrumentation. Note: Prior cholecystectomy with or without bile duct exploration is permitted.
• Tumor perfused by extrahepatic collateral arteries.
• Prior partial hepatectomy.
• Psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements.
• History of or current extrahepatic cancer.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ryan Lokken, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

(415) 514-8987; Maya.Aslam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Radiology

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)