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OncoMatch/Clinical Trials/NCT06261125

Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401)

Is NCT06261125 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Adebrelimab and Lenvatinib for hepatocellular carcinoma.

Phase 2RecruitingMian XINCT06261125Data as of May 2026

Treatment: Adebrelimab · LenvatinibAbdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: lenvatinib (lenvatinib)

Exception: patients who could not be tolerated

Patients who have previously been treated with lenvatinib or PD-1/PD-L1 antibody but could not be tolerated

Cannot have received: anti-PD-1/PD-L1 therapy

Exception: patients who could not be tolerated

Patients who have previously been treated with lenvatinib or PD-1/PD-L1 antibody but could not be tolerated

Cannot have received: abdominal radiotherapy

A history of abdominal radiotherapy

Lab requirements

Blood counts

WBC ≥ 3.0×10^9/L, ANC ≥ 1.5×10^9/L; platelets ≥ 50×10^9/L; hemoglobin ≥ 9g/dL

Kidney function

serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min

Liver function

Child-Pugh class A liver function; total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; serum albumin ≥ 2.8g/dL

Child-Pugh class A liver function; normal liver volume >700 ml; WBC ≥ 3.0×10^9/L, ANC ≥ 1.5×10^9/L; platelets ≥ 50×10^9/L; hemoglobin ≥ 9g/dL; serum albumin ≥ 2.8g/dL; total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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