HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion

The combination of HAIC with systemic therapy can provide superior efficacy compared to systemic therapy alone or local therapy alone for patients with advanced HCC complicated by vascular invasion, regardless of whether they have extrahepatic metastasis, with overall manageable safety. Currently, guidelines have recommended HAIC for HCC patients with unresectable primary tumors, PVTT type I/II/III/IV, and Child-Pugh A liver function, and recognize that its combination with sorafenib for patients with PVTT has superior efficacy compared to sorafenib monotherapy. However, more evidence is still needed regarding the efficacy of HAIC combined with lenvatinib and PD-1 inhibitors for patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion. This study aims to further validate the efficacy and safety of lenvatinib and PD-1 inhibitors ± HAIC for HCC patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion through larger sample size multicenter real-world data, with the goal of providing new evidence-based guidance for HCC treatment in clinical practice. This study is to evaluate the efficacy and safety of HAIC combined with lenvatinib and PD-1 inhibitors versus lenvatinib combined with PD-1 inhibitors in the first-line treatment of advanced hepatocellular carcinoma with major vascular or biliary invasion

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Age: 18-80 years, both genders;
* Diagnosed with hepatocellular carcinoma according to the Primary Liver Cancer Diagnosis and Treatment Guidelines (2019 edition) or pathological diagnosis;
* BCLC stage C with portal vein/hepatic vein/inferior vena cava/bile duct invasion, with or without extrahepatic metastasis;
* At least one measurable intrahepatic lesion according to RECIST 1.1 criteria;
* Received first-line lenvatinib + PD-1 inhibitor combination therapy or HAIC + lenvatinib + PD-1 inhibitor combination therapy between January 2020 to June 2024;
* ECOG PS score 0-1;
* Child-Pugh score: Class A or B (≤7); ALBI score: Grade 1-2.

Exclusion Criteria:

* Previous systemic therapy for HCC (including immune checkpoint inhibitors, tyrosine kinase inhibitors, anti-VEGF antibodies, etc.) and hepatic arterial chemotherapy;
* Received radiotherapy and other local treatments besides HAIC during treatment;
* Received other antitumor drug therapy during treatment;
* Previously diagnosed with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components by histology/cytology;
* Previously diagnosed with any other malignancy, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ that has been curatively treated;
* Incomplete outcome data or missing key baseline characteristic data.