Unresectable hepatocellular carcinoma
Conditions
Interventions
After the initial administration of atezolizumab + bevacizumab on Day 0, radiation therapy will be performed targeting, in principle, one lesion between Day 8 and Day 15.
Sponsors
Kodama Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 years or older at the time of informed consent. (2) Patients with a confirmed diagnosis of hepatocellular carcinoma by pathological or imaging findings. (3) Patients with hepatocellular carcinoma that is not amenable to local therapy, and who are BCLC stage B or stage C. (4) Patients with at least two measurable lesions according to RECIST v1.1. (5) Patients undergoing their first systemic drug therapy for hepatocellular carcinoma. However, a history of drug therapy as part of curative treatment more than 6 months ago is permitted. (6) Patients with an ECOG PS of 0 or 1. (7) Patients with Child-Pugh class A liver function. (8) Patients with an expected survival of at least 12 weeks. (9) Patients who can provide written informed consent for participation in this study.
Exclusion criteria
Exclusion criteria: (1) Patients for whom tumor evaluation by contrast-enhanced CT or contrast-enhanced MRI is difficult. (2) Patients receiving systemic administration of steroids or other immunosuppressants for the treatment of autoimmune diseases or other conditions. (3) Patients with interstitial pneumonia, pulmonary fibrosis, drug-induced pneumonitis, radiation pneumonitis, severe pulmonary emphysema, or a combination thereof. (4) Patients with active progressive cancer in other organs. (5) Patients receiving antithrombotic therapy. The following drugs are considered antithrombotic therapy, and the use of other drugs is permitted: * Antiplatelet agents: Aspirin, Ticlopidine, Clopidogrel, Prasugrel, Cilostazol * Anticoagulants: DOACs (Dabigatran, Rivaroxaban, Apixaban, Edoxaban), Warfarin (6) Patients with esophageal varices requiring prophylactic treatment for bleeding, as confirmed by contrast-enhanced CT, contrast-enhanced MRI, or endoscopic examination. (7) Patients with a history of immune checkpoint inhibitor therapy. (8) Patients with a history of radiation therapy within the planned irradiation field. (9) Patients with a history of hypersensitivity to components of atezolizumab or bevacizumab. (10) Patients with a history of hemoptysis. (11) Female patients who are pregnant, possibly pregnant, wishing to become pregnant, or breastfeeding, and male patients whose partners wish to become pregnant. (12) Patients participating in other clinical trials or planning to participate in other clinical trials during this study. (13) Patients whom the principal investigator or sub-investigator deems unsuitable as a study participant for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3 or higher adverse events that cannot be ruled out as related to the study treatment within 8 weeks after the completion of radiation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Incidence of Grade 3 or higher adverse events that cannot be ruled out as related to the study treatment over the entire study period. (2) Incidence of adverse events that cannot be ruled out as related to the study treatment over the entire study period. (3) Progression-free survival (PFS). (4) Objective response rate (ORR) and disease control rate (DCR). (5) Objective response rate (ORR) and disease control rate (DCR) for radiation-treated target lesions and non-target lesions. (6) 1-year survival rate and overall survival (OS). (7) Changes in tumor size percentage of RECIST v1.1 target lesions and radiation-treated target/non-target lesions over time (8) Changes in liver reserve function over time. (9) Proportion of patients transitioning to subsequent therapies. | — |
Contacts
Public ContactKazuki Maesaka
The University of Osaka Hospital
Outcome results
None listed