Leveraging Immunotherapy For Tumor Downstaging to Milan Criteria in Patients With Hepatocellular Carcinoma
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.
• Age ≥ 18 at the time of signing the Informed Consent Form.
• Beyond UCSF criteria HCC with diagnosis confirmed histologically/cytologically, radiologically, or clinically per AASLD criteria, with life expectancy of at least 12 months.
• Histologically confirmed HCC via liver biopsy obtained within 3 months prior to initiation of study treatment as part of SOC. If no historical biopsy is available, a biopsy must be performed at screening for confirmation. Screening liver biopsy may be conducted as part of research activities if not performed per SOC practice.
• ECOG performance status ≤ 2 within 7 days prior to initiation of study treatment.
• Child-Pugh A or B7 (5 to 7 points) at screening and within 7 days prior to study treatment. D1 ECOG/CTP may not repeat if screening ECOG/CTP collected within 7 days prior to D1.
• HCC with Measurable disease by mRECIST (see Appendix 11.2) (at least one ≥10mm target lesion) that is not suitable for resection per standard clinical practice and beyond UCSF criteria (see section 11.5) confirmed with most recent imaging obtained within 3 months prior to screening.
• For subjects of childbearing potential (SOCBP), negative serum or urine pregnancy test and agreement to use adequate contraception or abstinence from the time of screening until 3 months following the last dose of Durvalumab.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.