Resectable Hepatocellular Carcinoma With High Risk of RecurrenceMORNING-RWSNCT07064681
The Real-world Study of AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)
An observational study of Resectable Hepatocellular Carcinoma With High Risk of Recurrence, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Hepatocellular Carcinoma With High Risk of Recurrence
- What is being tested?
- Surgery with and without the aid of Indocyanine Green (ICG)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2025to 17 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Resectable HCC patients with high risk of recurrence
Who may be able to join
- Age ≥18 years but ≤75 years
- Resectable HCC staged BCLC A/B
- Treatment naïve for HCC
- High risk for recurrence, meeting at least one of the following criteria:
- Multiple tumor lesions
- Individual tumor > 5cm
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- AFP > 400 ug/L
- MVI positive based on preoperative MRI according to MVI predictive model of Radiomics
- Measurable or evaluable lesions according to RECIST v1.1 criteria
- ECOG performance status 0-1
- Child-Pugh class A
- Life expectancy ≥ 12 weeks
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count ≥ 1,500/μL
- Platelets count ≥ 75,000/μL
- Total serum bilirubin ≤ 1.5 ×upper limit of normal(ULN)
- AST and ALT ≤ 5 × ULN, ALP ≤ 4 ×ULN
- Serum creatinine ≤ 1.5 ×ULN
- INR ≤ 1.5 ×ULN, APTT ≤ 1.5 ×ULN
- Serum albumin ≥3.0 g/dL
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as assessed by the treating investigator are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Any prior treatment for HCC.
- Tumor rupture or bleeding. Suspected abdominal metastasis.
- A major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to enrollment.
- History of allogenic organ transplantation.
- Under other clinical trials.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: vitiligo or alopecia, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy or celiac disease controlled by diet alone.
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AK104 or other immune checkpoint inhibitors.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (including tuberculosis), uncontrolled hypertension (defined as blood pressure of > 140/90 mmHg during the screening period despite medical management), interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
- History of hepatic encephalopathy, refractory ascites or esophagogastric varices with high risk of bleeding. Upper gastrointestinal hemorrhage within the year prior to the first dose of study drug.
- Active hepatitis B infection without treatment (positive HBV surface antigen (HBsAg) and HBV DNA ≥ 1000 IU/ml). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Active hepatitis C infection (positive HCV antibody and HCV RNA above the lower limit of detection).
- A primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of a stroke within the year prior to the first dose of study drug.
- History of active primary immunodeficiency.
- History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study agent. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection). Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or its equivalent. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study drug and for at least 30 days after the last dose of study agent.
- Systemic immunostimulant therapy within 14 days prior to the first dose of study agent.
- History of serious systemic disease, including myocardial infarction or unstable angina within the 12 months prior to the first dose of study drug, hypertensive crisis or hypertensive encephalopathy, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication, significant vascular disease or symptomatic peripheral vascular disease.
- History of coagulopathy, bleeding diathesis, or thrombosis within the 12 months prior to the first dose of study drug.
- A serious, non-healing wound, ulcer, or bone fracture.
- Pregnancy or lactation.
- Total parenteral nutrition.
- Exclusion from the study by the judgement of investigators, due to some factors that may lead to the forced termination of the study, including other acute, chronic or psychological disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of SYSU
Guangzhou, Guangdong, 510080
tanli5@mail2.sysu.edu.cn
About this study
Official title: The Real-World Study of Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk
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.
Read the 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.
- Being tested
- Surgery with and without the aid of Indocyanine Green (ICG)
- Keywords
- Resectable Hepatocellular Carcinoma with High Risk of Recurrence, Real-world study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with and without the aid of Indocyanine Green (ICG)Procedure or surgery
Enrolled patients will receive surgery and be follow up for 2 years
| Study group | Role | What they receive |
|---|---|---|
| retrospective group | retrospective group Receives: Procedure: Surgery with and without the aid of Indocyanine Green (ICG) | |
| prospective group | prospective group Receives: Procedure: Surgery with and without the aid of Indocyanine Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence rate
1-year recurrence rate
Measured: 1-year recurrence rate
1-year recurrence rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start5 Jul 2025 (estimated)
- Primary completion17 Dec 2025 (estimated)
- Study completion17 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular Carcinoma With High Risk of RecurrenceStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Kuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064681
- Sponsor's protocol ID
- RWS2024
- Acronym
- MORNING-RWS
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real-World Study of Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk
- ClinicalTrials.gov ID
- NCT07064681
- Acronym / sponsor ID
- MORNING-RWS / RWS2024
- Keywords
- Resectable Hepatocellular Carcinoma with High Risk of Recurrence, Real-world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Jul 2025 (estimated)
- Primary completion
- 17 Dec 2025 (estimated)
- Study completion
- 17 Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective group | – | Procedure: Surgery with and without the aid of Indocyanine Green (ICG)retrospective group |
| prospective group | – | Procedure: Surgery with and without the aid of Indocyanine Green (ICG)prospective group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Resectable HCC patients with high risk of recurrence
Key inclusion criteria (24 listed)
- Age ≥18 years but ≤75 years
- Resectable HCC staged BCLC A/B
- Treatment naïve for HCC
- High risk for recurrence, meeting at least one of the following criteria:
- Measurable or evaluable lesions according to RECIST v1.1 criteria
Key exclusion criteria (22 listed)
- Any prior treatment for HCC.
- Tumor rupture or bleeding. Suspected abdominal metastasis.
- A major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to enrollment.
- History of allogenic organ transplantation.
- Under other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery with and without the aid of Indocyanine Green (ICG)Enrolled patients will receive surgery and be follow up for 2 years | Procedure or surgery | prospective group, retrospective group |
Primary outcome
1-year recurrence rate
Time frame: 1-year recurrence rate
1-year recurrence rate
1-year recurrence rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Hepatocellular Carcinoma With High Risk of Recurrence, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Kuang, Doctor (008687755766 Ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence rate (time frame: 1-year recurrence rate). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.