About this trial
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).
Eligibility criteria
Qualifiers
Patient is willing, able and mentally competent to provide written informed consent prior to any testing undertaken for this study protocol, including screening tests and evaluations that are not considered to be part of the patient's routine care.
Male and female patients, age 21 to 90 at the time of signature of the informed consent form.
Patient is able to comply with scheduled visits, assessments and other study procedures.
Patient diagnosed with HCC or its histological variants who has undergone a resection within 4-12 weeks prior to Day 1 of Cycle 1.
Disqualifiers
Patient is unable to provide informed consent or refuse blood taking.
Patient has evidence of residual, recurrent, or metastatic disease prior to initiation of treatment.
Patient has clinically significant ascites or any other clinical signs of liver failure on physical examination at time of enrolment.
Patient has a history of hepatic encephalopathy.
Trial design
Treatments tested in this trial
- Surgical Resection
- Adjuvant Atezolizumab-Bevacizumab Therapy
Treatment groups
Sponsors and collaborators
National Cancer Centre, Singapore
Lead sponsor
Singapore General Hospital
Collaborator
National University Hospital, Singapore
Collaborator
Changi General Hospital
Collaborator
Sengkang General Hospital
Collaborator
Tan Tock Seng Hospital
Collaborator
Singapore Clinical Research Institute
Collaborator
Genome Institute of Singapore
Collaborator
Institute of Molecular and Cell Biology of Singapore
Collaborator
Cancer Science Institute of Singapore
Collaborator
Duke-NUS Graduate Medical School
Collaborator
Singapore Phenome Centre
Collaborator
Nanyang Technological University
Collaborator
NMRC OF-LCG (OFLCG21Jun-0016)
Collaborator