NCT06059885

Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC

Tislelizumab Plus Tyrosine Kinase Inhibitor (TKI) as Adjuvant Therapy Versus Active Surveillance in Patients With HCC at High Risk of Recurrence After Curative Ablation: A Prospective Cohort Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS. Adjuvant atezolizumab + bevacizumab (IMbrave 050) showed RFS improvement following curative resection or ablation. Currently, there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC. This is an open-label, prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor (TKI) as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation.

Conditions

• Liver Neoplasms

Interventions

Type	Name	Description
DRUG	Tislelizumab plus tyrosine kinase inhibitor	Lenvatinib, tyrosine kinase inhibitor (TKIs)

Timeline

• Start date: 2021-12-22
• Primary completion: 2025-03-31
• Completion: 2025-12-20
• First posted: 2023-09-29
• Last updated: 2023-09-29

Locations

1 site across 1 country: China