Actively Recruiting
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
Led by National Cancer Centre, Singapore · Updated on 2025-10-06
100
Participants Needed
14
Research Sites
274 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of locally advanced hepatocellular carcinoma (HCC) confined to the liver without extra-hepatic metastases
- Tumor burden beyond up-to-7 criteria and/or vascular invasion VP 1-3 and/or Vv 1-2
- Age 21 years or older of any gender
- Eligible for SIRT-Y90 treatment based on macro-aggregated albumin Tc-99m MAA scan criteria
- No prior radiation to the liver
- No prior systemic adjuvant or neoadjuvant therapy for HCC
- Measurable disease with at least one lesion 610 mm on CT or MRI
- Negative HIV test, or if positive, stable on anti-retroviral therapy with CD4 count 100/bcL and undetectable viral load
- Documented hepatitis B or C virology status
- For active HBV: HBV DNA 3000 IU/mL, on anti-HBV treatment at least 14 days prior to randomization, willing to continue treatment
- ECOG performance status of 0 or 1
- Child-Pugh class A with up to 6 points
- Adequate hematologic, renal, and liver function according to defined laboratory criteria
- Life expectancy of at least 3 months without active treatment
- Suitable for protocol treatment by clinical assessment
- Esophagogastroduodenoscopy performed within 6 months prior to randomization with complete treatment of varices
- Able and willing to provide written informed consent
- Female participants must be postmenopausal or have a negative pregnancy test and agree to contraception during and after treatment
- Male participants must be surgically sterile or agree to contraception during and after treatment
You will not qualify if you...
- Not eligible for SIRT-Y90 treatment after Tc-99m MAA scan assessment
- Serious adverse events greater than grade 3 within 4 weeks after SIRT-Y90
- More than 2 prior hepatic artery directed therapies
- Hepatic artery therapy within 4 weeks prior to consent
- Prior systemic adjuvant or neoadjuvant therapy for HCC
- Prior hepatic radiation therapy for HCC or other cancers
- Received immunotherapy within 30 days prior to randomization or planned during study
- Less than 30% disease-free liver volume
- Receiving other investigational cancer treatments
- Intractable ascites or other signs of liver failure
- Untreated or incompletely treated esophageal or gastric varices
- Tumor thrombus beyond VP3 or Vv2 locations
- Presence of metastatic disease
- Other active malignancies except certain treated skin or cervical cancers
- Clinical signs of central nervous system metastases
- Uncontrolled or serious intercurrent illnesses limiting study compliance
- Uncontrolled high blood pressure despite treatment
- Contraindications to angiography or catheterization including bleeding disorders or severe vascular disease
- Significant cardiovascular disease or unstable heart conditions
- History of congenital long QT syndrome or prolonged QT interval
- Uncorrectable electrolyte disorders affecting potassium, calcium, or magnesium
- Recent use of aspirin above 325 mg/day or certain antiplatelet drugs
- Recent use of full-dose anticoagulants or thrombolytics for therapeutic purposes
- History of allergic reactions to study treatments
- Active or history of autoimmune or immune deficiency diseases with certain exceptions
- Need for systemic immunosuppressive or immunostimulant agents or chronic corticosteroids
- Unable or unwilling to provide informed consent
- Pregnant or breastfeeding females
- Currently enrolled in another investigational drug or device study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, China
Actively Recruiting
2
People's Liberation Army General Hospital (1st and 6th Medical Centre)
Beijing, China
Not Yet Recruiting
3
West China Hospital, Sichuan University
Chengdu, China
Actively Recruiting
4
Shandong Cancer Hospital
Jinan, China
Not Yet Recruiting
5
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
6
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
7
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
8
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
9
Severance Hospital Yonsei University Health System
Seoul, South Korea
Actively Recruiting
10
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
11
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
12
National Taiwan University Cancer Center
Taipei, Taiwan
Actively Recruiting
13
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
14
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
P
Professor Pierce CHOW, MD, PhD
CONTACT
V
Vennese LOW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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