TACE in Combination With Tislelizumab and Lenvatinib for Advanced HCC (CHANCE2602)

Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. Tislelizumab is a PD-1 monoclonal antibody approved by the National Medical Products Administration (NMPA) of China for first-line and second-line treatment of patients with HCC. The purpose of this real-world study is to evaluate the safety and efficacy of TACE in combination with Tislelizumab and Lenvatinib in patients with advanced-stage HCC.

Inclusion criteria

• Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients who meet the clinical diagnostic criteria for primary liver cancer;
• Age ≥18 years at the time of HCC diagnosis;
• Barcelona Clinic Liver Cancer (BCLC) stage C;
• No prior systemic therapy for HCC (including chemotherapy, molecular targeted therapy, or immunotherapy);
• Received treatment with tislelizumab and lenvatinib, with the interval between the first administration of the two drugs ≤1 week;
• In the experimental group, TACE was performed within 3 months before or after treatment with tislelizumab and lenvatinib;
• After TACE, patients received at least one cycle of combination therapy with tislelizumab and lenvatinib, including cTACE and DEB-TACE;
• Child-Pugh class A5 to B7;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
• At least one measurable intrahepatic lesion according to RECIST 1.1 criteria.

Exclusion criteria

• Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma histological types;
• Complete obstruction of the main portal vein with insufficient collateral compensation;
• Uncontrollable ascites or hepatic encephalopathy;
• Incomplete clinical data or missing essential information;
• Presence of other primary malignant tumors in addition to the diagnosis of liver cancer;
• Participation in other interventional studies prior to treatment;
• Other conditions deemed unsuitable for inclusion by the investigators.