NCT07064681

The Real-world Study of AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)

The Real-World Study of Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study. All patients who meet the inclusion criteria of our previous Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma, but refuse to receive neoadjuvant treatment will be asked again to participate this observational study retrospectively and prospectively. Participants will receive surgery and regular monitoring for 1 year. The purpose is to provide real-world cohort for comparison with the neoadjuvant cohort.

Detailed description

This study will first retrospectively enroll the patients who meet the inclusion criteria of our previous neoadjuvant trial but refuse to receive neoadjuvant treatment. Then prospective enrollment will be taken following the same rules at the same of our neoadjuvant trial. Every enrolled patient will receive surgery without neoadjuvant therapy. Long-term survival follow-up will be conducted as well.

Conditions

• Resectable Hepatocellular Carcinoma With High Risk of Recurrence

Interventions

Type	Name	Description
PROCEDURE	Surgery with and without the aid of Indocyanine Green (ICG)	Enrolled patients will receive surgery and be follow up for 2 years

Timeline

• Start date: 2025-07-05
• Primary completion: 2025-12-17
• Completion: 2026-12-17
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: China