OncoMatch/Clinical Trials/NCT05809869
Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma
Is NCT05809869 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Tremelimumab for hepatocellular carcinoma.
Treatment: Durvalumab · Tremelimumab — Hepatocellular carcinoma is one of the most intractable primary malignancies in the hepatobiliary and pancreatic tract with a poor overall survival worldwide. Unfortunately, the vast majority of hepatocellular carcinoma patients suffer from advanced unresectable or metastatic disease at diagnosis. Currently targeted therapy alone, or in combination with anti-vascular endothelial growth factor antagonist, is the standard first-line treatment for metastatic hepatocellular carcinoma. On the other hand, there is growing evidence suggesting that radiation therapy (external or internal) with or without immune checkpoint inhibitors can produce or even augment abscopal effect in which the tumours away from the radiation field also show significant tumour shrinkage. The underlying mechanism of eliciting abscopal effect includes the increased antigen presentation by the myeloid cells within the tumour stroma leading to enhanced tumour cell killing. Previous case reports showed that radiation therapy alone can induce abscopal effect in mice and human models. However, a robust and concrete evidence of abscopal effect with combinational immune checkpoint inhibitors and radioembolisation or external radiation therapy in hepatocellular carcinoma is still lacking. This study investigates the efficacy and safety of immune checkpoint inhibitors and radioembolisation as first-line treatment for previously untreated metastatic hepatocellular carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: monoclonal antibody
Has had a prior monoclonal antibody, immunotherapy or immune checkpoint inhibitors before recruitment into this study.
Cannot have received: immunotherapy
Has had a prior monoclonal antibody, immunotherapy or immune checkpoint inhibitors before recruitment into this study.
Cannot have received: immune checkpoint inhibitor
Has had a prior monoclonal antibody, immunotherapy or immune checkpoint inhibitors before recruitment into this study.
Cannot have received: chemotherapy
Exception: within 3 weeks prior to administration of the study drug or who has not recovered (i.e., grade ≤1 or at baseline) from adverse events due to a previously administered agent
Has had prior chemotherapy or targeted small molecule therapy (including sorafenib or other anti-vascular endothelial growth factor inhibitor) within 3 weeks prior to administration of the study drug or who has not recovered (i.e., grade ≤1 or at baseline) from adverse events due to a previously administered agent.
Cannot have received: targeted small molecule therapy (sorafenib, anti-vascular endothelial growth factor inhibitor)
Exception: within 3 weeks prior to administration of the study drug or who has not recovered (i.e., grade ≤1 or at baseline) from adverse events due to a previously administered agent
Has had prior chemotherapy or targeted small molecule therapy (including sorafenib or other anti-vascular endothelial growth factor inhibitor) within 3 weeks prior to administration of the study drug or who has not recovered (i.e., grade ≤1 or at baseline) from adverse events due to a previously administered agent.
Cannot have received: radiation therapy
Exception: if experienced Grade 4 toxicity on treatment with prior radiation
Has experienced Grade 4 toxicity on treatment with prior radiation.
Cannot have received: intracranial radiation
Exception: if experienced grade 3-4 intracranial toxicity (hypophysitis or central nervous system toxicity)
Has experienced grade 3-4 intracranial toxicity (hypophysitis or central nervous system toxicity) with either prior intracranial radiation, anti-programmed cell death-1 (PD-1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor therapy.
Cannot have received: anti-PD-1 therapy
Exception: if experienced grade 3-4 intracranial toxicity (hypophysitis or central nervous system toxicity)
Has experienced grade 3-4 intracranial toxicity (hypophysitis or central nervous system toxicity) with either prior intracranial radiation, anti-programmed cell death-1 (PD-1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor therapy.
Cannot have received: anti-CTLA-4 therapy
Exception: if experienced grade 3-4 intracranial toxicity (hypophysitis or central nervous system toxicity)
Has experienced grade 3-4 intracranial toxicity (hypophysitis or central nervous system toxicity) with either prior intracranial radiation, anti-programmed cell death-1 (PD-1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor therapy.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.0 x 10^9/l; Platelet ≥75 x 10^9/l; Haemoglobin ≥9 g/dL
Kidney function
Measured creatinine clearance (CL) >40 mL/min or calculated creatinine CL >40 mL/min by Cockcroft-Gault formula or 24-hour urine collection.
Liver function
Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). AST/ALT ≤2.5x ULN unless liver metastases are present, in which case ≤5x ULN. Exception: Gilbert's syndrome allowed with physician consultation.
Cardiac function
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) <470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
Adequate serum hematological functions defined as: Absolute neutrophil count (ANC) ≥1.0 x 10^9/l Platelet ≥75 x 10^9/l Haemoglobin ≥9 g/dL. Adequate serum biochemistry functions defined as: Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)...Serum aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤2.5 times of institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5 times of ULN. Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula...Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify