OncoMatch/Clinical Trials/NCT06605664
Hyperpolarized 13C-MRI in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy, Atezolizumab, and Bevacizumab
Is NCT06605664 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for hepatocellular carcinoma (hcc).
Increased pyruvate-to-lactate conversion is a hallmark of HCC metabolism. In parallel, activation of pro-inflammatory immune cells triggers a metabolic switch towards anaerobic glycolysis. Hyperpolarized carbon-13 (13C) pyruvate MRI is a state-of-the-art non-invasive imaging method that offers real-time insights into tissue metabolism. Recent studies have demonstrated its promising potential in predicting responses to radiotherapy and immunotherapy in solid tumors, given the significance of pyruvate as a downstream metabolite in glycolysis. However, its application in assessing treatment response in hepatocellular carcinoma (HCC) patients remains unclear. The establishment of quantitative imaging biomarkers for predicting responses to radio-immunotherapy is an unmet need in the management of HCC patients. While radiotherapy (RT) effectively controls localized tumors through the induction of unrepairable DNA double-stranded breaks (DSBs) and cell death, its therapeutic efficacy on distal, non-irradiated tumor cells is limited, with out-of-field recurrence being a common pattern of failure in HCC patients treated with high-dose irradiation. Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) in conjunction with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) has recently emerged as the standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an objective response rate (ORR) of only 27%, the majority of patients succumb to HCC progression and liver failure. Our preclinical study (Hsieh et al., Science Immunology 2022) uncovered that RT, when combined with PD-L1/PD-1 blockade, induces immunogenic cell death and tumor antigen cross-presentation in antigen-presenting cells, enhancing systemic antitumor T cell responses in murine tumor models. Recent retrospective cohorts suggest that RT targeting all hepatic tumors combined with PD-L1/programmed death-1 (PD-1) blockade is associated with an improved ORR and median progression-free survival (PFS) in patients with unresectable HCC, demonstrating a favorable safety profile. The synergistic antitumor effects of this combination therapy with RT, atezolizumab, and bevacizumab have led to its increasing adoption in routine clinical practice. This phase II non-randomized trial aims to prospectively investigate the predictive value of hyperpolarized 13C-MRI, along with comprehensive metabolomics and radiomics analyses, for immune response assessment including tumor control outcomes and toxicity in patients with HCC undergoing radiotherapy, atezolizumab, and bevacizumab.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BARCELONA CLINIC LIVER CANCER (BCLC) STAGES INTERMEDIATE (B) OR ADVANCED (C) (BCLC)
Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Exception: to the region of the liver that would result in overlap of radiation therapy fields
Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
Cannot have received: selective internal radiotherapy/hepatic arterial yttrium therapy
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Cannot have received: solid organ transplantation
Prior solid organ transplantation
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,000/mm3; Platelet count ≥ 50,000/μL
Kidney function
Serum creatinine ≤ 1.5 mg/dL
Liver function
Total bilirubin < 2.5 mg/dL; Serum albumin >2.8 g/dL; ALT and AST ≤ 3 × ULN; Prothrombin time ≤ 6 seconds prolonged; Child-Pugh score 5-6 liver function within 28 days of study registration
Adequate bone marrow, liver, and renal function within 4 weeks before study registration * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1,000/mm3 * Platelet count ≥ 50,000/μL * Total bilirubin < 2.5 mg/dL * Serum albumin >2.8 g/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) * Prothrombin time ≤ 6 seconds prolonged * Serum creatinine ≤ 1.5 mg/dL Child-Pugh score 5-6 liver function within 28 days of study registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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