Assessing Therapy Response with Ga-68 PSMA-11 PET/CT in Patients with Advanced Hepatocellular Carcinoma Treated with Atezolizumab/Bevacizumab
- Conditions
- Neoplasms
- Registration Number
- KCT0008748
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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