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RECRUITING
NCT06313190
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-04-05

Completion Date

2030-04-30

Last Updated

2024-11-18

Healthy Volunteers

No

Interventions

RADIATION

Stereotactic 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.

DRUG

Sintilimab

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