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NCT06313190

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
Sun Yat-sen University·Phase 2·ClinicalTrials.gov·radiationNot yet recruiting
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Study focus
Disease/Condition
Hepatocellular Carcinoma
Drug/Device/Intervention
Stereotactic body radiotherapy
Study type
Interventional
Intervention type
radiation
Sponsor & location
Primary sponsor
Sun Yat-sen University
Location
Guangzhou, China
Timeline & enrollment
Phase
Phase 2
Start date
Apr 05, 2024
End date
Apr 30, 2030
Enrollment
140 participants
Primary outcome

Progression-free survival (PFS) rate

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.

ICD-10 classifications
Malignant neoplasm: HepatoblastomaMalignant neoplasm: Liver cell carcinomaMalignant neoplasm: Other specified carcinomas of liverMalignant neoplasm: Liver, unspecifiedMalignant neoplasm: Hepatic flexure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06313190
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06313190 through Pure Global AI's free database. This Phase 2 trial is sponsored by Sun Yat-sen University and is currently Not yet recruiting. The study focuses on Hepatocellular Carcinoma. Target enrollment is 140 participants.

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