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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.

Phase 2RecruitingRutgers, The State University of New JerseyNCT05366829Data as of May 2026

Treatment: TislelizumabThe 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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