Adjuvant Tislelizumab Plus Lenvatinib for Patients at High-risk of HCC Recurrence After Curative Resection or Ablation

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Though hepatic resection and ablation are the curative treatments for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced or unresectable HCC. No study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy is reported.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangxi Medical University
• Treatments: Lenvatinib; Tislelizumab

Criteria

Inclusion Criteria:

• Age from 18 to 75 years (inclusive);

• Diagnosis of HCC confirmed by postoperative histopathology;

• Underwent curative resection, as defined based on intra- and postoperative criteria;

• With high-risk factors of recurrence after curative treatment, based on preoperative radiological imaging or pathology reports indicating a tumor at least 5 cm in diameter, micro- or macrovascular invasion (Vp1/Vp2), satellite or multinodular tumors, and/or Grade 3/4 pathology;

• No residual cancer detected by radiological imaging in the liver within 8 weeks after curative resection;

• Child-Pugh 5-7 scores liver function;

• Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria:

• Received neoadjuvant immune checkpoint inhibitors or tyrosine kinase inhibitors before resection or ablation;

• A history of other malignancies;

• History of active autoimmune or immunodeficiency diseases;

• Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;

• Loss to follow-up within six months.