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

NCT07064681 | Recruiting

• 1 other identifier: RWS2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resectable Hepatocellular Carcinoma With High Risk of Recurrence

Keywords

Resectable Hepatocellular Carcinoma with High Risk of Recurrence; Real-world study

Outcome Measures

Primary Outcomes (2)

• 1-year recurrence rate

  1-year recurrence rate

  1-year recurrence rate

• 1-year recurrence rate

  1 year

Study Arms (2)

retrospective group

retrospective group

Procedure: Surgery with and without the aid of Indocyanine Green (ICG)

prospective group

prospective group

Procedure: Surgery with and without the aid of Indocyanine Green (ICG)

Interventions

Surgery with and without the aid of Indocyanine Green (ICG) PROCEDURE

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

prospective group; retrospective group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Resectable HCC patients with high risk of recurrence

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The first affiliated hospital of SYSU

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Ming Kuang, Doctor

CONTACT

008687755766 Ext. 8576; kuangm@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 15, 2025
• Study Start: July 5, 2025
• Primary Completion: December 17, 2025
• Study Completion (Estimated): December 17, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CN (1)