RecruitingPhase 2

Deep, Multi-omics Phenotyping to Predict Response, Resistance and Recurrence to Adjuvant Atezolizumab Plus Bevacizumab in Resected Hepatocellular Carcinoma

Singapore30 participantsStarted 2023-02-28

Plain-language summary

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).

Who can participate

Age range21 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Patient has clinically AND histologically proven HCC after liver resection as described below:
✓. Patient has an absence of major macrovascular (gross vascular) invasion of the portal vein (Vp3 or Vp4) or major macrovascular invasion in the inferior vena cava (Vv3).
✓. Patient has an absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following resection . If head scan was not performed prior to resection, this must be performed after resection.
✓. Patient has a full recovery from surgical resection within 4 weeks prior to Day 1 of Cycle 1.

What they're measuring

Recurrence-free-survival (RFS) in relation to the multi-omics (epigenomics, genomics, transcriptomics, proteomics and metabolomics) and spatial TME profiles of both tissue and peripheral blood.

Timeframe: Up to 4 Years after surgery.

Trial details

NCT IDNCT05516628

SponsorNational Cancer Centre, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Pierce CHOW, MD, PhD

+65 6436 8000 pierce.chow@duke-nus.edu.sg

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials

Plain-language summary

Who can participate

Age range21 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Patient has clinically AND histologically proven HCC after liver resection as described below:
✓. Patient has an absence of major macrovascular (gross vascular) invasion of the portal vein (Vp3 or Vp4) or major macrovascular invasion in the inferior vena cava (Vv3).
✓. Patient has an absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following resection . If head scan was not performed prior to resection, this must be performed after resection.
✓. Patient has a full recovery from surgical resection within 4 weeks prior to Day 1 of Cycle 1.

Deep, Multi-omics Phenotyping to Predict Response, Resistance and Recurrence to Adjuvant Atezolizumab Plus Bevacizumab in Resected Hepatocellular Carcinoma

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Deep, Multi-omics Phenotyping to Predict Response, Resistance and Recurrence to Adjuvant Atezolizumab Plus Bevacizumab in Resected Hepatocellular Carcinoma

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria