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.
• 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
‣ 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.