Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Unresectable Hepatocellular Carcinoma
Conditions
Brief summary
This phase II trial tests whether 68-Gallium prostate specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) imaging can improve the diagnosis and management of liver cancer that has spread to other parts of the body (advanced). PSMA is a protein that appears in large amounts on the surface of liver cancer cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. A PET scan is then used to detect the location of the tumor cells. 68Ga-PSMA PET may improve upon the diagnosis and management of liver cancer.
Detailed description
PRIMARY OBJECTIVES: I. To test the performance of novel biomarkers derived from PSMA PET/computed tomography (CT) to measure response compared to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in advanced hepatocellular carcinoma (HCC) patients treated with immunotherapy. II. To identify precision imaging biomarkers that can predict response of HCC to novel immunotherapy. OUTLINE: Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed-up every 6 months for 3 years.
Interventions
PROCEDUREComputed Tomography
Undergo 68Ga PSMA PET/CT
Undergo 68Ga PSMA PET/CT
PROCEDUREPositron Emission Tomography
Undergo 68Ga PSMA PET/CT
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies * Have radiographically measurable disease by RECIST * Eligible for atezolizumab/bevacizumab front line therapy * Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent
Exclusion criteria
* Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan * Patients with higher than the weight/size limitations of PET/CT scanner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Response | 36 weeks | Defined as the time from study registration to complete response/partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and per PSMA positron emission tomography (PET)/computed tomography (CT). |
| Proportion of Progression Free Survival (PFS) at 6 Months | 6 months | Defined as the length of time during and after treatment that a patient lives with cancer without the disease worsening, per RECIST and PSMA PET/CT |
| Time to Progression | 32 months | Defined as the time from study registration to disease progression per RECIST 1.1 and PSMA PET/CT. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNguyen H. Tran, MD
Mayo Clinic in Rochester
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 7.57 |
| BMI | 29.5 kg/m^2 STANDARD_DEVIATION 5.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 24 |
| other Total, other adverse events | 9 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
None listed