Hepatocellular carcinoma
Conditions
Interventions
Atezolizumab plus bevacizumab treatment Particle radiotherapy
Sponsors
Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older at the time of consent 2. PS 0 or 1 3.Child-Pugh Classification A 4. No more than moderate ascites and no hepatic encephalopathy 5. Hepatocellular carcinoma diagnosed by imaging or histology 6. Diagnosed as unresectable and the main lesion is greater than 4 cm in length 7. Intrahepatic lesions meet one of the following a. not meeting Up-to-7 criteria b. portal vein tumor thrombus (Vp2-4) and/or inferior vena cava tumor thrombus(Vv2, 3) 8. Multiple intrahepatic lesions which delivering curative irradiation of particle therapy deemed impossible. 9. No extrahepatic metastases 10. Patients who have been fully informed of the details of this study and have given their free and voluntary written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with multiple cancers. Patients with multiple cancers, but no signs of recurrence for at least 5 years after completion of treatment, and patients with epithelial cancer or endoscopically resectable gastrointestinal cancer within 5 years of completion of treatment may be enrolled. 2.Patients with untreated or poorly treated esophageal and/or gastric varices with or at high risk of bleeding. Patients who have undergone esophagogastroduodenoscopy prior to enrollment and who have been evaluated and treated for all varices, large or small, according to the institution's standard of care, and who are judged to have a low risk of bleeding may be enrolled. 3. Patients who are judged to be inappropriate to participate in this study by the principal investigator or sub-investigator. 4. Patients who are judged to be inappropriate according to the latest practice guideline for the use of atezolizumab/bevacizumab combination therapy. 5. Other patients deemed inappropriate by the study investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate Tumor size reduction rate (irradiated and non-irradiated lesions) Objective response rate (RECIST) Overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactShohei Komatsu
Kobe University Graduate School of Medicine Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Outcome results
None listed