Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk: A Phase II, Single-arm Clinical Trial
This is a Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma. The purpose is to investigate the efficacy and safety of this therapeutic regimen to reduce the risk of postoperative recurrence in resectable HCC patients with a high risk of recurrence.
• 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.