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

Phase 3

Not yet recruiting

• Conditions: Hepatocellular Carcinoma; Recurrence; Immune Checkpoint Inhibitor
• Interventions: Drug: Adjuvant tislelizumab plus lenvatinib; Drug: Adjuvant tislelizumab

• Registration Number: NCT05910970
• Lead Sponsor: Guangxi Medical University

Brief 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.

Detailed Description

Hepatic resection and ablation are the best treatments for patients with early stage hepatocellular carcinoma (HCC) or selected intermediate or advanced disease. However, the postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause of death. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC by official guidelines. At the same time, four randomizead controlled trials about adjvuant immune checkpoint inhibitors for postoperative HCC are ongoing. A prospective cohort study found adjuvant immune checkpoint inhibitors with or without tyrosine kinase inhibitors may improve recurrence-free survival of patients at high-risk of HCC recurrence after curative resection (DOI: 10.1200/JCO.2023.41.16_suppl.4119. Journal of Clinical Oncology 41, no. 16_suppl. 4119). Therefore, the investigators plan to compare the safety and efficacy of adjuvant Tislelizumab plus lenvatinib to Tislelizumab monotherapy for patients with high-risk factor of HCC recurrence after curative resection and ablation in a multicentric, prospective study.

Study Timeline

• Study First Submitted: 2023-06-11
• Study First Submitted QC: 2023-06-11
• Study First Posted: 2023-06-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Study Start: 2024-02-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant tislelizumab plus lenvatinib	Adjuvant tislelizumab plus lenvatinib	Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab plus lenvatinib treatment for six months, HCC recurrence, or unacceptable adverse events.
Adjuvant tislelizumab	Adjuvant tislelizumab	Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab treatment for six months, HCC recurrence, or unacceptable adverse events.

Primary Outcome Measures

Name	Time	Method
Recurrene-free survival	3 years	Recurrene-free survival will be calculated using the Kaplan-Meier method, and differences between groups are assessed for significance using the log-rank test.

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years	Overall survival will be calculated using the Kaplan-Meier method, and differences between groups are assessed for significance using the log-rank test.
Adverse events	1 years	Adverse events are expressed as number and percentage.

Trial Locations

Locations (1)

Jian-Hong Zhong; 🇨🇳 Nanning, China