NCT06984718

A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC

A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination With Lenvatinib Versus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have progressed on the first line treatment of atezolizumab and bevacizumab.

Conditions

• HCC
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	AK104+lenvatinib	Subjects will receive AK104+lenvatinib until disease progression
DRUG	lenvatinib	Subjects will receive lenvatinib until disease progression

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-11-30
• Completion: 2027-06-30
• First posted: 2025-05-22
• Last updated: 2025-05-22

Regulatory

• FDA-regulated drug study