RecruitingNCT07064681

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


Sponsor

Sun Yat-sen University

Enrollment

100 participants

Start Date

Jul 5, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This real-world study (called MORNING) investigates whether combining a liver-directed procedure called TACE (where chemotherapy is delivered directly into the blood vessel feeding a liver tumor) with an immunotherapy drug (AK104) before surgery improves outcomes for people with resectable liver cancer at high risk of recurrence. **You may be eligible if...** - You are between 18 and 75 years old - You have liver cancer (hepatocellular carcinoma) at an early or intermediate stage (BCLC A or B) suitable for surgical removal - You have not received any prior treatment for your liver cancer - Your cancer has at least one high-risk feature for recurrence: multiple tumors, a single tumor larger than 5 cm, elevated AFP blood marker (above 400), or specific MRI findings suggesting vascular invasion - Your liver function and blood counts are adequate **You may NOT be eligible if...** - You have already received treatment for liver cancer - Your liver function or overall health is poor - Your cancer is not resectable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgery with and without the aid of Indocyanine Green (ICG)

Enrolled patients will receive surgery and be follow up for 2 years


Locations(1)

The first affiliated hospital of SYSU

Guangzhou, Guangdong, China

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NCT07064681


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