Actively Recruiting
Deep, Multi-omics Phenotyping to Predict Response, Resistance and Recurrence to Adjuvant Atezolizumab Plus Bevacizumab in Resected Hepatocellular Carcinoma
Led by National Cancer Centre, Singapore · Updated on 2025-06-17
30
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
S
Singapore General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) is the 7th most common cancer worldwide but is the 4th deadliest, because diagnosis tend to be late and current systemic therapies are poorly efficacious. Within the same tumour, different parts of the HCC can belong to separate molecular sub-groups. In addition, there is currently no validated predictive biomarkers to help clinicians select the best therapy for an individual patient. This challenge poses an urgent, unmet clinical need. To address this, the multi-disciplinary research program Precision Medicine in Liver Cancer across an Asia-Pacific Network (PLANet 1.0) was conceptualized and successfully conducted from 2016-22. The program uncovered novel insights into the highly heterogeneous molecular landscape of HCC and novel mechanisms, including how HCC reverts to fetal forms to escape the body's immunological defence. These investigations will be continued in PLANet 2.0 and in this new phase, the research team will investigate patients receiving best-in-class therapeutics in 2 investigator-initiated clinical studies (AHCC12 and AHCC13), including Atezolizumab plus Bevacizumab (Atezo+Bev) and Yttrium-90, which allows the research team to collect longitudinal, before and after treatment biosamples and clinical data. These clinical studies will serve as proof-of-concept to the study team's translational findings and allow it to uncover predictive biomarkers which will help clinicians to institute more efficacious and personalized treatment in the future. The research team comprises of experts in different complementary fields (epigenomics, genomics, immunomics, metabolomics, proteomics, clinical science and data science) and across different institutions. This allows the team to adopt an integrative approach in understanding the landscape of the HCC tumour micro-environment and biomarkers co-localisation, and their role in tumour evolution and therapeutic response. By adopting a wide spectrum of converging investigations, PLANet 2.0 will identify and validate biomarkers that correlate with clinical outcomes (response, resistance and recurrence).
CONDITIONS
Official Title
Deep, Multi-omics Phenotyping to Predict Response, Resistance and Recurrence to Adjuvant Atezolizumab Plus Bevacizumab in Resected Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is willing, able and mentally competent to provide written informed consent prior to any testing for this study.
- Male and female patients aged 21 to 90 years at the time of consent.
- Patient able to comply with scheduled visits, assessments, and study procedures.
- Diagnosed with hepatocellular carcinoma or its histological variants and underwent surgical resection 4 to 12 weeks before starting treatment.
- Histologically confirmed HCC with negative surgical margins (R0) documented in pathology report.
- Disease-free status documented within 4 weeks before starting treatment, with no residual or recurrent disease.
- No major macrovascular invasion (portal vein Vp3/Vp4 or inferior vena cava Vv3).
- No extrahepatic spread confirmed by CT or MRI scans before and after resection.
- Full recovery from surgery within 4 weeks prior to treatment start.
- High risk for HCC recurrence defined by tumor characteristics (beyond up-to-7 criteria or macrovascular invasion Vp1/Vp2).
- Negative for HIV infection.
- Documented hepatitis virology status; for active HBV, HBV DNA < 500 IU/mL and on anti-HBV treatment.
- Willingness to undergo esophagogastroduodenoscopy and electrocardiogram before treatment.
- Child-Pugh score A (up to 6 points) without clinical ascites before surgery.
- ECOG performance status 0-1.
- Adequate hematologic, renal, and hepatic function as defined by laboratory tests within 7 days before treatment.
- Estimated life expectancy of at least 3 months without active treatment.
- Suitable for protocol treatment as determined by investigator.
- Women must be postmenopausal or have negative pregnancy test and agree to contraception; men must use contraception if sexually active with premenopausal partners.
You will not qualify if you...
- Unable to provide informed consent or refuse blood sampling.
- Evidence of residual, recurrent, or metastatic disease before treatment.
- Clinically significant ascites or signs of liver failure at enrollment.
- History of hepatic encephalopathy.
- Bleeding due to untreated or incompletely treated esophageal/gastric varices before treatment.
- Active or history of autoimmune disease or immune deficiency, except certain controlled conditions.
- History of lung diseases such as idiopathic pulmonary fibrosis or active pneumonitis.
- Significant cardiovascular disease or unstable conditions within 3 months before treatment.
- History of other malignancies within 5 years, except low-risk cancers.
- Active tuberculosis or severe infection within 4 weeks before treatment.
- Recent therapeutic antibiotic treatment within 2 weeks before treatment.
- Prior allogeneic stem cell or organ transplantation.
- On waiting list for liver transplantation.
- Any condition contraindicating investigational drug use or increasing treatment risk.
- Co-infection with HBV and HCV or Hepatitis D.
- Clinically significant uncontrolled or symptomatic hypercalcemia.
- Severe allergic reactions to antibodies or components of study drugs.
- Prior HCC treatments other than planned surgery, with specific exceptions.
- Recent live attenuated vaccine use or planned use during study period.
- Prior investigational therapy or immune checkpoint treatments within specified time frames.
- Use of systemic immunosuppressive medications within 2 weeks before treatment, with exceptions.
- Poorly controlled hypertension or history of hypertensive crisis.
- Significant vascular disease or recent thrombotic events.
- Recent bleeding or coagulopathy issues.
- Recent core biopsy or minor surgery within 3 days before treatment.
- History of serious abdominal inflammatory conditions within 6 months.
- Pregnant or breastfeeding women or those intending pregnancy during study period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
National University Hospital Singapore
Singapore, Singapore, 119074
Actively Recruiting
2
National Cancer Centre Singapore
Singapore, Singapore, 169610
Actively Recruiting
3
Singapore General Hospital
Singapore, Singapore, 169856
Actively Recruiting
4
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Active, Not Recruiting
5
Changi General Hospital
Singapore, Singapore, 529889
Actively Recruiting
6
Sengkang General Hospital
Singapore, Singapore, 544886
Actively Recruiting
Research Team
P
Pierce CHOW, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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