NCT05925413

Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma

Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Eastern Hepatobiliary Surgery Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with TACE in patients with intermediate-stage unresectable hepatocellular carcinoma.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab+TACE	Cadonilimab: 15mg/kg Q3W Day1 Select the best TACE treatment strategy. Traditional TACE (cTACE) or DEB-TACE can be selected. TACE treatment can be continued as needed based on disease control. The combination of cadonilimab is given 3 to 7 days after the first TACE treatment, and the subsequent administration of cardonilizumab is given once every 3 weeks, if the time overlaps with TACE treatment, it is generally administered 3 to 7 days after TACE treatment. Treatment was discontinued until intolerable toxicity, death, withdrawal of informed consent, initiation of a new antitumor therapy, or other reason specified in the protocol, whichever occurs first. Patients in this study received cadonilimab for up to 24 months.

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-07-30
• Completion: 2025-07-30
• First posted: 2023-06-29
• Last updated: 2023-06-29

Locations

1 site across 1 country: China