hepatocellular carcinoma hepatocellular carcinoma
Conditions
Interventions
[Carbon Ion Radiotherapy (CIRT)]
Carbon Ion Radiotherapy (CIRT) is performed for 4 consecutive operating days (in principle within 1 week, and in the event of postponement of irradiation, the treatmen
D061605,D063193
Atezolizumab/Bevacizumab/Carbon Ion Radiotherapy (CIRT)
Sponsors
Ogasawara Sadahisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary Enrollment 1) Patients who are at least 18 years of age at the time of consent 2) Patients with primary hepatocellular carcinoma 3) Patients with an ECOG PS of 0 or 1 4) Patients who meet the following criteria in laboratory tests 1)Hemoglobin >= 9.0 g/dL 2) Neutrophil count >= 1,500/mm3 3) Platelet count >= 60,000/mm3 4) AST = 9.0 g/dL 2) Neutrophil count >= 1,500/mm3 3) Platelet count >= 60,000/mm3 4) AST <= 5 x ULN 5) ALT <= 5 x ULN 6) Total bilirubin <= 3.0 x ULN 7) Creatinine <= 1.5 x ULN 8) Urinary protein less than 2+. In case of 2+ or more, urinary protein/creatinine ratio in urine at any time: less than 1.0 5) Patients with no new intrahepatic lesions or extrahepatic metastases confirmed by chest, abdomen, pelvic region and CT or MRI scan
Exclusion criteria
Exclusion criteria: Primary Enrollment 1) Patients participating in another clinical trial using an investigational drug within 28 days prior to obtaining consent 2) Patients who received radiotherapy within 4 weeks prior to enrollment 3) Patients with a history of allogeneic organ transplantation 4) Patients with active overlapping cancers. However, duplicate cancers that do not have a defined prognosis and do not require active treatment, such as early-stage cancer, are acceptable. 5) Patients with infectious diseases (except viral hepatitis) that have systemic treatment 6) Patients with a history of active primary immunodeficiency 7) Women who are pregnant, possibly pregnant, or lactating. Patients who are pregnant or lactating. Male patients who wish to carry their partner to term. 8) Patients with psychiatric disorders or concomitant psychiatric symptoms that interfere with daily life or are judged to be incompetent to give their consent, making it difficult for them to participate in the study. 9) Patients receiving continuous systemic administration of steroids (prednisone equivalent > 10 mg/day) or other immunosuppressive drugs for the treatment of autoimmune or other diseases 10) Patients taking antiplatelet or anticoagulant drugs for therapeutic (not prophylactic) purposes 11) Patients with a history of hepatic encephalopathy within 3 months prior to enrollment (including the same date 3 months prior to enrollment) 12) Patients with a history of rupture of esophageal or gastric varices or with esophageal or gastric varices with bleeding risk (Form >=F2 or RC sign based on the 3rd edition of the Japanese Code of Medical Practice for Portal Hypertension) on upper gastrointestinal endoscopy within 6 months prior to enrollment (including the same date 6 months prior to the date of enrollment) Patients with esophageal or gastric varices with a risk of bleeding on portal hypertension. Patients who have been treated prophylactically for esophageal or gastric varices by the standard methods of the implementing institution prior to enrollment and are judged not to be at risk for bleeding may be enrolled. 13) Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema, as diagnosed by imaging studies (chest X-ray, CT), or with one or more complications. 14) Patients with serious complications (heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction) 15) Patients complicated with poorly controlled hypertension or poorly controlled diabetes mellitus (patients may be enrolled if they are controllable prior to enrollment). 16) Patients with unstable angina pectoris or a history of myocardial infarction within 6 months prior to enrollment. 17) Patients who have received treatment for blood (including blood transfusions, blood products or hematopoietic factor products such as G-CSF) within 14 days prior to enrollment 18) Patients with a history of radiation therapy with liver effects prior to enrollment 19) Patients with a history of hypersensitivity to any component of the investigational drug 20) Patients with conditions that are contraindicated in the package insert. 21) Patients who are judged by the investigator or subinvestigator to be inappropriate for this study. Secondary Enrollment 1) Patients with radiation lung injury due to heavy particle irradiation that does not recover to Grade 1 or below 2) Patients with gastrointestinal disorders associated with heavy particle irradiation that do not recover
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [phase Ib] Proportion of patients with dose-limiting toxicities (DLTs) [phase II] 1-year recurrence-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| [phase Ib] Incidence of adverse events (AEs) and serious adverse events (SAEs) 1-year recurrence-free survival rate, Overall survival, 6-month survival rate [phase II] 2-year recurrence-free survival rate, Overall survival, 6-month survival Rate | — |
Contacts
Public ContactAsahi Takahashi
Chiba University Hospital
Outcome results
None listed