RecruitingPhase 2NCT05377034

Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients

A Multinational, Double-blind, Placebo-Controlled, Parallel Randomized Arms, Phase II Trial to Compare Safety and Efficacy of Selective Internal Radiation Therapy (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab) Versus Selective Internal Radiation Therapy (SIRT-Y90) Followed by Placebo in Patients With Locally Advanced Hepatocellular Carcinoma (HCC)


Sponsor

National Cancer Centre, Singapore

Enrollment

100 participants

Start Date

Oct 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-national, phase II, parallel-arm, double-blind, placebo-controlled, two-arm study designed to assess the efficacy and safety of SIRT-Y90 followed by atezolizumab plus bevacizumab \[study arm\], versus SIRT-Y90 followed by placebo \[control arm\] in patients with locally advanced Hepatocellular Carcinoma (HCC).


Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This international Phase II study is comparing two treatment approaches for advanced liver cancer (HCC) that cannot be surgically removed: a targeted internal radiation treatment (called Y-90 SIRT, which delivers radiation beads directly to the liver tumor) followed by either an immunotherapy combination (atezolizumab + bevacizumab) or a placebo. **You may be eligible if...** - You have been diagnosed with liver cancer (HCC) that is confined to the liver but is large or has grown into nearby blood vessels - You have not received prior systemic (whole-body) treatment for HCC - Your liver is functioning adequately (Child-Pugh A or B7) - You have a decent overall health status **You may NOT be eligible if...** - Your liver cancer has spread outside the liver - You have had prior systemic cancer therapy for HCC - You have autoimmune conditions or certain liver conditions that would make immunotherapy unsafe - Your liver function is significantly impaired 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

COMBINATION_PRODUCTSIRT-Y90 with Atezolizumab + Bevacizumab

Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by 1200mg atezolizumab + 15mg/kg bevacizumab administered by IV at every 3 weeks for 18 months.

COMBINATION_PRODUCTSIRT-Y90 with Placebo (IV)

Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by placebo at every 3 weeks for 18 months.


Locations(14)

Beijing Tsinghua Changgung Hospital

Beijing, China

People's Liberation Army General Hospital (1st and 6th Medical Centre)

Beijing, China

West China Hospital, Sichuan University

Chengdu, China

Shandong Cancer Hospital

Jinan, China

National University Hospital

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Cancer Center

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05377034


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