OncoMatch/Clinical Trials/NCT05366829
Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
Is NCT05366829 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab for carcinoma, hepatocellular.
Treatment: Tislelizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC A, BCLC B, BCLC C (BCLC)
BCLC A-C or deemed not a candidate for surgery or liver transplantation; Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: transarterial chemoembolization
prior TACE permitted
Cannot have received: immunotherapy
Participants who have received prior immunotherapy
Cannot have received: selective internal radiotherapy/hepatic arterial Yttrium therapy
Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time
Cannot have received: radiotherapy to the region of the liver
Exception: if would result in excessive doses to normal tissues due to overlap of radiation therapy fields
Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL
Kidney function
Serum creatinine OR calculated serum creatinine clearance ≤ 1.5x ULN OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN; Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment; if ≥ 2+, 24-hour urine collection must demonstrate < 1g of protein in 24 hours
Liver function
Child-Pugh class A liver function or B7; Serum total bilirubin ≤ 3 mg/dL, AST (SGOT) and ALT (SGPT) ≤ 5x ULN, Alkaline phosphatase (ALP) ≤ 8x ULN, INR/PT/aPTT ≤ 2.0x ULN (if not on anticoagulation)
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 ≤ 1.5x ULN OR ≥ 30 mL/min...; Hepatic - Serum total bilirubin ≤ 3 mg/dL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - INR/PT/aPTT ≤ 2.0x ULN (if not on anticoagulation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
- Montefiore Medical Center · The Bronx, New York
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