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.
Treatment: Sintilimab — For 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.
Check if I qualifyExtracted 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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