OncoMatch/Clinical Trials/NCT05516628
Deep, Multi-omics Phenotyping to Predict Response, Resistance and Recurrence to Adjuvant Atezolizumab Plus Bevacizumab in Resected Hepatocellular Carcinoma
Is NCT05516628 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adjuvant Atezolizumab-Bevacizumab Therapy for hepatocellular carcinoma.
Treatment: Adjuvant Atezolizumab-Bevacizumab Therapy — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: HIV negative
Patient is known to be negative for the Human Immunodeficiency Virus (HIV).
Allowed: HBV active infection
For patients with active HBV: HBV DNA < 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to Day 1 of Cycle 1 and willingness to continue anti-HBV treatment during the study
Allowed: HCV resolved or chronic infection
Patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidenced by detectable HCV RNA), are eligible
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — resection within 4-12 weeks prior to Day 1 of Cycle 1
Patient diagnosed with HCC or its histological variants who has undergone a resection within 4-12 weeks prior to Day 1 of Cycle 1.
Cannot have received: systemic therapy
Exception: planned surgery only; prior HCC resection >5 years ago allowed as de-novo
Patient has received any treatment for HCC prior to resection, including previous liver resection, systemic therapy (including investigational agents) and locoregional therapy (e.g. RFA, TACE, SIRT), radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy other than the planned surgery.
Cannot have received: immunotherapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, CD137 agonists)
Patient has prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cannot have received: systemic immunostimulatory agents (interferon, interleukin-2)
Patient has received prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to Day 1 of Cycle 1
Cannot have received: systemic immunosuppressive medication (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumour necrosis factor-α (TNF-α) agents)
Exception: acute, low-dose, or one-time pulse dose; mineralocorticoids; corticosteroids for COPD/asthma; low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency allowed
Patient has received prior treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor-α [TNF-α] agents) within 2 weeks prior to Day 1 of Cycle 1, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions...
Cannot have received: investigational therapy
Patient has received prior treatment with investigational therapy within 4 weeks prior to Day 1 of Cycle 1
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L (9 g/dL); Platelet count ≥ 75 × 10**9/L (75,000/µL) without transfusion; Lymphocyte count ≥ 0.5 × 10**9/L (500/µL); ANC ≥ 1.5 × 10**9/L (1500/µL) without G-CSF support
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min (Cockcroft-Gault)
Liver function
AST, ALT, and ALP ≤ 5 × ULN; Serum bilirubin ≤ 3 × ULN; Albumin ≥ 28 g/L (2.8 g/dL); Child-Pugh A (up to 6 points) without clinical ascites before surgery
Cardiac function
Willing to receive an electrocardiogram prior to Day 1 of Cycle 1
Patient has adequate hematological, renal and hepatic function, defined by the following laboratory test results, obtained within 7 days prior to Day 1 of Cycle 1 unless otherwise specified: AST, ALT, and ALP ≤ 5 × ULN; Serum bilirubin ≤ 3 × ULN; Albumin ≥ 28 g/L (2.8 g/dL); Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min (Cockcroft-Gault); Hemoglobin ≥ 90 g/L (9 g/dL); Platelet count ≥ 75 × 10**9/L (75,000/µL) without transfusion; Lymphocyte count ≥ 0.5 × 10**9/L (500/µL); ANC ≥ 1.5 × 10**9/L (1500/µL) without G-CSF support; For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 2 × ULN; Urine dipstick for proteinuria < 2 + (within 7 days prior to Day 1 of Cycle 1)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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