The investigators are doing this study to learn if a combination of immunotherapy and a liver-directed tumor procedure can safely and effectively shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to try to lower the stage of the cancer so that more patients may become eligible for a liver transplant. The investigators will also closely watch for side effects from the study treatments. Section 2 has more details.
The investigators are doing this study to learn if a combination of immunotherapy and a liver-directed tumor procedure can safely and effectively shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to try to lower the stage of the cancer so that more patients may become eligible for a liver transplant. The investigators will also closely watch for side effects from the study treatments. What are the study treatments? The patients will receive immunotherapy medicines through a vein (IV). The first treatment is a combination of tremelimumab and durvalumab, called STRIDE. After that, the patients may continue durvalumab about once every 4 weeks up to total of 12 cycles on study. The patients will also have a liver-directed tumor treatment (LRT), which is a procedure to treat the tumor inside the liver. Depending on what is best for the patients, this may include Yttrium-90 (Y90) (radiation delivered inside the liver), TACE (chemotherapy delivered directly to the liver tumor through a small tube placed in a blood vessel), or RFA (heat used to destroy the tumor). These procedures are done by a specialist using imaging guidance, and the patients may receive medicine to help the patients relax or sleep. The patients will be monitored during and after the procedure. The patients are being asked to take part in this research study because the patients have intermediate or advanced hepatocellular carcinoma (HCC). The U.S. Food and Drug Administration (FDA) has approved those drugs as they are being used in this study. Another purpose of this study is for researchers to learn if a biomarker test is helpful in determining long-term effects of ICI. A biomarker is a biological molecule found in blood, other body fluids or tissues. Biomarkers may be a sign of a condition or disease. Biomarkers also can be used to predict patient's response to a specific treatment. The study will include up to 41 patients total.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
• To assess the success rate of combining ICIs and LRT (as neoadjuvant treatment) in tumor downstaging to Milan Criteria within 12 months of baseline STRIDE treatment in patients with HCC exceeding the University of California San Francisco (UCSF) criteria.
Cedars Sinai
Los Angeles, California, United States
RECRUITINGProportion of participants downstaged from beyond UCSF criteria to within Milan criteria by radiographic assessment
The primary outcome is the proportion of enrolled participants with hepatocellular carcinoma who are successfully downstaged from disease burden exceeding UCSF criteria at baseline to within Milan criteria within 12 months after initiation of STRIDE-based therapy and locoregional treatment. Downstaging status will be determined by follow-up contrast-enhanced CT or MRI using the study's predefined imaging assessment criteria.
Time frame: 12 month
Proportion of participants downstaged from beyond UCSF criteria to within Milan criteria by radiographic assessment
This secondary outcome measure is the proportion of participants with hepatocellular carcinoma who are successfully downstaged from tumor burden exceeding UCSF criteria at baseline to within Milan criteria within 12 months after initiation of STRIDE therapy combined with locoregional treatment. Downstaging status will be determined by contrast-enhanced CT or MRI using the study's predefined imaging assessment criteria.
Time frame: 12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.