RecruitingPhase 2NCT06313190

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

Stereotactic Body Radiotherapy With or Without Adjuvant Immunotherapy for Small Hepatocellular Carcinoma: An Open-label, Randomized, Phase II Trial

Sponsor

Sun Yat-sen University

Enrollment

140 participants

Start Date

Apr 5, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a focused radiation technique called SBRT with immunotherapy drugs improves outcomes for patients with small liver cancer (hepatocellular carcinoma) that has returned or was not fully treated previously. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of liver cancer (hepatocellular carcinoma) - You have residual or recurrent liver tumors: total tumor diameter 5 cm or less, no more than 2 tumors, and no spread to blood vessels or outside the liver - Your liver function is reasonably good (Child-Pugh class A) with adequate remaining liver volume - Your general fitness is acceptable (ECOG score 2 or less) - Any previous targeted therapy or chemotherapy ended at least 6 months ago **You may NOT be eligible if...** - You have active spread of cancer beyond the liver or into blood vessels - Your liver function is significantly impaired (Child-Pugh B or C) - Your overall health status is poor (ECOG above 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic body radiotherapy

Patients in both cohorts will receive SBRT using volumetric arc therapy. The prescribed dose is 30-54 Gy in 3 fractions over 1 week.

DRUGSintilimab

Patients received sintilimab 200 mg every 3 weeks for up to 6 cycles, with the first dose within 1 week after the completion of SBRT.

Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06313190

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