Actively Recruiting
The Real-world Study of AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)
Led by Sun Yat-sen University · Updated on 2025-07-15
100
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Real-world Study of AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Resectable hepatocellular carcinoma (HCC) staged BCLC A or B
- No prior treatment for HCC
- High risk for recurrence, defined by at least one: multiple tumors, tumor larger than 5 cm, AFP above 400 ug/L, or MVI positive on MRI
- Measurable or evaluable lesions per RECIST v1.1
- ECOG performance status 0-1
- Child-Pugh class A liver function
- Life expectancy of at least 12 weeks
- Adequate organ and marrow function including hemoglobin ≥9.0 g/dL, neutrophils ≥1,500/μL, platelets ≥75,000/μL, bilirubin ≤1.5× ULN, AST and ALT ≤5× ULN, ALP ≤4× ULN, creatinine ≤1.5× ULN, INR ≤1.5× ULN, APTT ≤1.5× ULN, albumin ≥3.0 g/dL
- Negative pregnancy test for women of childbearing potential
- Patients with prior or concurrent malignancies not affecting safety or efficacy assessment
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Any prior treatment for hepatocellular carcinoma
- Tumor rupture, bleeding, or suspected abdominal metastasis
- Major surgery, open biopsy, or significant injury with poorly healed wound within 6 weeks before enrollment
- History of allogenic organ transplantation
- Participation in other clinical trials
- Active or prior autoimmune or inflammatory disorders (with some exceptions like vitiligo or stable hypothyroidism)
- History of allergic reactions to AK104 or similar immune checkpoint inhibitors
- Uncontrolled illnesses including active infections, uncontrolled hypertension, interstitial lung disease, serious gastrointestinal conditions, or psychiatric/social conditions limiting compliance
- History of hepatic encephalopathy, refractory ascites, or high-risk esophagogastric varices; recent upper gastrointestinal hemorrhage
- Active untreated hepatitis B or active hepatitis C infection
- Brain tumors, brain metastases, uncontrolled seizures, or recent stroke
- Active primary immunodeficiency
- HIV/AIDS history
- Use of immunosuppressive medication within 14 days prior to study drug (with specified exceptions)
- Receipt of live vaccines within 30 days prior to study drug
- Systemic immunostimulant therapy within 14 days prior to study drug
- Serious cardiovascular diseases within 12 months prior to study drug
- History of coagulopathy, bleeding, or thrombosis within 12 months prior to study drug
- Serious non-healing wounds, ulcers, or bone fractures
- Pregnancy or breastfeeding
- Receiving total parenteral nutrition
- Other acute, chronic, or psychological diseases that may force study termination as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The first affiliated hospital of SYSU
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
M
Ming Kuang, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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