NCT06361758

Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC

Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC: A Single Arm, Multicenter, Phase II Trial. (SCALE)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab+Lenvatinib	Cadonilimab (AK104): 15mg/kg Q3W iv D1 + Lenvatinib: 8 mg (body weight \<60 kg) or 12mg (body weight ≥60 kg) orally QD. Eligible patients will receive AK104 plus Lenvatinib until disease progression or withdrawn ICF or death, whichever comes first.

Timeline

• Start date: 2024-05-31
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2024-04-12
• Last updated: 2025-05-23

Locations

3 sites across 1 country: China