None listed
Conditions
Interventions
Others : PET/CT Imaging ar 60 minutes after Ga-68 PSMA-11 iv injection
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible in this clinical trial. ? Patients aged 19 or older at the time of signing the consent form ? Histologically or radiologically confirmed HCC that meets the American Association for the Study of Liver Diseases (AASLD) diagnostic criteria ? BCLC (Barcelona Clinic Hepatocellular Cancer) stage B or C ? Liver function of Child-Pugh class A ? General performance of ECOG (Eastern Oncology Cooperation Group) 0 or 1 ? Atezolizumab/bevacizumab to be treated
Exclusion criteria
Exclusion criteria: Subjects who fall under any of the following criteria are excluded from this clinical trial. ? Fibrous laminar carcinoma or mixed hepatic/biliary tract cancer ? Patients who have previously undergone systemic chemotherapy for HCC (but can be registered if intravenous anticancer drugs are used during TACE) ? Patients who has undergone liver transplantation ? Cases where other primary cancers other than HCC have been diagnosed within five years or have occurred simultaneously (except where other primary cancers have been treated and completely recovered) ? Subjects are under severe and/or uncontrolled and/or unstable medical conditions judged by the investigator (e.g., congestive heart failure, acute myocardial infarction, cerebral infarction, severe lung disease, chronic renal disease or chronic liver disease, etc.) ? Patients who have difficulty undergoing Ga-68 PSMA-11 PET/CT image (Dystonia, claustrophobia, etc.) ? Patients who cannot undergo contrast-enhanced CT or MR imaging due to renal dysfunction or contrast agent allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between changes in tumor uptake on Ga-68 PSMA-11 PET/CT after the first cycle of atezolizumab/bevacizumab and the RECIST v1.1 based response evaluation, using tri-phase liver CT after the third cycle of atezolizumab/bevacizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between tumor uptake on baseline Ga-68 PSMA-11 PET/CT and the RECIST v1.1 based response evaluation, using tri-phase liver CT after the third cycle of atezolizumab/bevacizumab ;Correlation between changes in tumor uptake on Ga-68 PSMA-11 PET/CT after the first cycle of atezolizumab/bevacizumab and progression-free survival & overall survival | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Eun Kim
Asan Medical Center
Outcome results
None listed