RecruitingPhase 2NCT06707233

Y-90 SIRT for Unresectable HCC Larger Than 7cm

Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

33 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating Y-90 radioembolization (a procedure that delivers radiation directly into liver tumors via tiny beads injected into the blood vessels feeding the tumor) for people with large, inoperable liver cancer (hepatocellular carcinoma, HCC) with the largest tumor over 7 centimeters. **You may be eligible if...** - You have confirmed liver cancer (HCC), either by biopsy or by clinical/imaging criteria - Your tumor is too large or advanced to be removed by surgery - Your largest tumor is greater than 7 cm - Your liver function and blood counts are adequate - You are in good overall health (ECOG performance status 0-1) - Your life expectancy is at least 6 months - Your cancer has not spread to major blood vessels **You may NOT be eligible if...** - Your tumor has grown into major blood vessels (macrovascular invasion) - Your liver function is severely impaired - Other conditions that make this procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESIRT

The patients will receive 1-2 sessions of SIRT.


Locations(2)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT06707233


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