NCT07047586

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab: a Multicenter, Randomized, Phase 2 Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of lenvatinib plus tislelizumab versus lenvatinib alone for patients with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.

Detailed description

This is a phase 2, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of lenvatinib plus tislelizumab versus lenvatinib alone in participants with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab will be administered by IV, 200 mg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
DRUG	Lenvatinib	Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Timeline

• Start date: 2025-07-02
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2025-07-02
• Last updated: 2025-07-03

Locations

1 site across 1 country: China