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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT05377034•National Cancer Centre, Singapore

View on ClinicalTrials.gov

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).

Detailed Description

This study will enroll 100 patients randomized in a 1:1 allocation ratio (50 in each arm) to one of the two arms. * Study arm: SIRT-Y90 + 1200mg atezolizumab + 15mg/kg bevacizumab * Control arm: SIRT-Y90 + placebos (IV) The patients will be recruited from up to 15 sites from the Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group (subjected to feasibility studies and ethics approval). Proposed sites are in Singapore, China, South Korea, and Taiwan.

Eligibility

Age

21 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must fulfill all of the following criteria to be eligible for this study:
•1. Unequivocal diagnosis of HCC (AASLD 2010 diagnostic criteria or histology) that is locally advanced without extra-hepatic metastases but with significant tumor burden, i.e.,
•* Tumor confined to the liver that is beyond the up-to-7 criteria, and/or
•* Tumor with vascular invasion VP 1-3 and/or Vv 1-2 (at the discretion of site investigator) Both local and central assessments are required at screening, prior to any study treatment. Sites are required to send all CT/MRI images for central imaging review. The central assessment result will be made known to sites and will take precedence in determining a patient's study eligibility in case of a discrepancy between local and central review.
•2. Aged 21 years old and above of either gender.
•3. Patient eligible for SIRT-Y90 treatment after assessment with macro-aggregated albumin labeled with technetium-99 (Tc-99m MAA) scan on SPECT/CT or planar imaging with all of the following criteria prior to each SIRT-Y90 treatment:
•* Lung shunting \<20% on SPECT/CT or planar imaging
•* Lung dose limit of \<25Gy for single treatment or \<30Gy for cumulative treatment (second delivery within 4-6 weeks)
•4. No prior radiation to the liver.
•5. No prior systemic adjuvant or neoadjuvant therapy for HCC.
+30 more criteria

Exclusion Criteria

•The following criteria should be checked. If ANY apply, the patient must not be included in the study:
•2. Patients who have SAE \> grade 3 within 4 weeks after receiving SIRT-Y90. For patients who experience SAE \> grade 3 after receiving SIRT-Y90 (1st or 2nd administration), the duration between the SIRT-Y90 dose and randomization and/or 1st and 2nd SIRT-Y90 dose (for two-staged delivery) may be extended by an additional 4 weeks to re-assess the patient's eligibility.
•3. Patients who have had \>2 administrations of hepatic artery directed therapy.
•4. Patients who have had hepatic artery directed therapy done \<4 weeks prior to date of ICF signing.
•5. Patients who have had systemic adjuvant or neoadjuvant therapy for HCC.
•6. Prior hepatic radiation therapy for HCC or other malignancy.
•7. Patient who has received any immunotherapy (including interferon-alfa, peginterferon alfa-2a, peginterferon alfa-2b, thymosin-α1, etc.) within 30 days prior to randomization, is currently receiving immunotherapy or is planned to start immunotherapy during the study (e.g., for the management of active CHB or CHC according to local guidelines).
•8. Has evidence that \<30% of the total liver volume is disease-free.
•9. Currently receiving any other investigational agents for the treatment of their cancer.
•10. Has intractable clinical ascites (in spite of optimal diuretic treatment) or any other clinical signs of liver failure, on physical examination.
+31 more criteria

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

Key Dates

Start Date

October 26, 2022

Primary Completion Date

July 25, 2026

Completion Date

January 31, 2028

Last Updated

October 6, 2025

Enrollment

100

ESTIMATED participants

Conditions

Locally Advanced Hepatocellular Carcinoma

Interventions

SIRT-Y90 with Atezolizumab + Bevacizumab

COMBINATION_PRODUCT

SIRT-Y90 with Placebo (IV)

COMBINATION_PRODUCT

Contacts

Professor Pierce CHOW, MD, PhD

CONTACT

+65 6436 8000 pierce.chow.k.h@singhealth.com.sg

Vennese LOW

CONTACT

+65 6306 5456 low.minxiu.vennese@nccs.com.sg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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