NCT05578430

AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)

Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk: A Phase II, Single-arm Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma. The purpose is to investigate the efficacy and safety of this therapeutic regimen to reduce the risk of postoperative recurrence in resectable HCC patients with a high risk of recurrence.

Detailed description

The trial will recruit 54 patients. At the first step, 26 patients will be recruited. Only when at least 10 patients achieve major pathological response after surgery will the trial enter the second step and continue to recruit other patients. After being enrolled, all patients giving written informed consent will receive TACE plus 2-cycle of Cadonilimab treatment before surgery. Four weeks later after surgery, Cadonilimab treatment will be followed up to 16 cycles. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Conditions

• Resectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab	10mg/kg by intravenous infusions every 3 weeks
PROCEDURE	TACE	TACE will be performed per institutional standard of care.
PROCEDURE	Surgery	Surgery will be performed per institutional standard of care.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2022-10-13
• Last updated: 2022-12-15