Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic disease and improve one year progression-free survival rates for participants and optimize local control.
• Each patient eligible to participate in this study must meet all the following criteria:
‣ Written informed consent
⁃ Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted
⁃ Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5
⁃ Eastern Cooperative Oncology Group performance status score of 0-2
⁃ Age\>/=18 years
⁃ Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation
⁃ No extrahepatic metastasis detected on CT chest with or without IV contrast, abdomen and pelvis with IV and oral contrast (triphasic-if feasible based on kidney function), or MRI abdomen/liver and chest CT.
⁃ Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 6 months after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days of first dose of study drug
⁃ Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 6 months after the last dose of tislelizumab. Males must agree not to donate or bank sperm during treatment with tislelizumab and for \> 6 months after treatment stop.
‣ Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1.
‣ Demonstrate adequate bone marrow and organ function as defined below:
• Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin \> 8.5 g/dL, Platelet count ≥ 75,000/mcL
∙ Renal - Serum creatinine OR calculated\* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels \> 1.5x institutional ULN
⁃ Calculate serum creatinine clearance using the standard Cockcroft-Gault formula.
• Urine protein Urine dipstick for proteinuria \< 2+ within 7 days prior to start of study treatment \*Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate \< 1g of protein in 24 hours
∙ Hepatic - Serum total bilirubin ≤ 3 mg/dL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN \*This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.