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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059885
• Other study ID #: ChiECRCT20210555
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2021
• Est. completion date: December 20, 2025

Study information

• Verified date: September 2023
• Source: Beijing 302 Hospital
• Contact: Fanping Meng
• Phone: 010-66933219
• Email: drmengfanping[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible patients are =18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria:

solitary tumor >2cm but =5cm, or multiple tumors =4tumors and all=5cm; poor tumor differentiation; macrovascular invasion of the portal vein(Vp1/Vp2) ; the absence or infiltration of a tumor capsule ; AFP=32ng/ml; HBV DNA =105IU/ml; history of recurrence after curative treatment; family history of tumors.

Exclusion Criteria:

Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Drug:
• Tislelizumab plus tyrosine kinase inhibitor
Lenvatinib, tyrosine kinase inhibitor (TKIs)

Locations

Country	Name	City	State
China	302 Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor recurrence rate (DRR)	Thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed before radical treatment, thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed after adjuvant treatment, and then thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed every 12 weeks. Tumor changes were evaluated by imaging. In addition, we will evaluate adverse events and death events: classify and grade adverse events, record the time and cause of death of patients. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	52 weeks