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OncoMatch/Clinical Trials/NCT06313190

Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)

Is NCT06313190 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab for hepatocellular carcinoma.

Phase 2RecruitingSun Yat-sen UniversityNCT06313190Data as of May 2026

Treatment: SintilimabFor inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy (SBRT) is an effective and safe local treatment. Despite satisfactory local control rate, the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9% to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC is unclear. The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual small HCC.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

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

Prior therapy

Cannot have received: immune checkpoint inhibitor

Patients who have previously been treated with immune checkpoint inhibitors

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; normal liver volume greater than 700 ml

The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 50×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min; Child-Pugh class A liver function; normal liver volume greater than 700 ml

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

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