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

Last updated: September 22, 2023
Sponsor: Beijing 302 Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Liver Cancer

Primary Biliary Cholangitis

Treatment

Tislelizumab plus tyrosine kinase inhibitor

Clinical Study ID

NCT06059885
ChiECRCT20210555
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology orcytology, with no prior targeted or immune checkpoint therapy for HCC, and haveundergone curative ablation with no residual lesions according to imaging orpathological assessment. Patients are at high risk of recurrence meeting one of thefollowing criteria: solitary tumor >2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm; poor tumordifferentiation; macrovascular invasion of the portal vein(Vp1/Vp2) ; the absence orinfiltration of a tumor capsule ; AFP≥32ng/ml; HBV DNA ≥105IU/ml; history of recurrenceafter curative treatment; family history of tumors.

Exclusion

Exclusion Criteria: Concurrent with other primary malignant tumors; severe coagulation dysfunction or severethrombocytopenic purpura; There is serious infection or organ failure; have previouslyreceived targeted drugs or other PD-1 antibody therapy;

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Tislelizumab plus tyrosine kinase inhibitor
Phase: 2
Study Start date:
December 22, 2021
Estimated Completion Date:
December 20, 2025

Connect with a study center

  • 302 Hospital

    Beijing, Beijing 100039
    China

    Active - Recruiting

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