HAIC vs. TACE Combined With ICIs and TKIs in Intermediate-to-Advanced HCC: A Multicenter Study on Liver Injury and Survival

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Liver Injury; Hepatecellular Carcinoma; HAIC(Hepatic Artery Infusion Chemotherapy); TACE(Transcatheter Arterial Chemoembolization)

Study type: Observational

Funder types: Other

Identifiers

NCT07277192

NFEC-2023-571

Details and patient eligibility

About

The purpose of this study is to compare the liver injury induced by HAIC combined with PD-1/PD-L1 inhibitors and TKIs versus triple therapy with TACE in the treatment of patients with advanced HCC; to compare the efficacy of the two triple therapy regimens in the treatment of patients with advanced HCC.

Enrollment: 562 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients voluntarily join this study and sign the informed consent form;
• Aged ≥ 18 years, both male and female;
• Patients with pathologically or clinically confirmed BCLC stage B or C hepatocellular carcinoma (HCC) who were diagnosed between January 1, 2019, and December 31, 2022;
• Receiving treatment with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs are only approved post-market medications, including but not limited to those with HCC indications);
• Transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) completed within 3 months after the first systemic treatment or within 1 month before the first systemic treatment;
• Having at least one measurable intrahepatic lesion, with intrahepatic lesions being the main tumor burden. (According to RECIST v1.1, the measurable lesion has a spiral CT scan long diameter ≥ 10 mm or enlarged lymph node short diameter ≥ 15 mm).

Exclusion criteria

• Pathologically/histologically confirmed cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma;
• Patients with a history of other malignant tumors within the past 3 years or concurrent malignant tumors (except cured basal cell carcinoma of the skin and cervical in situ carcinoma);
• Concomitant use of other antitumor therapeutic agents, such as antitumor traditional Chinese medicines and proprietary Chinese medicines;
• Patients who do not meet the definition of combination therapy;
• Incomplete medical information, such as lack of post-treatment imaging evaluation;
• Patients with immunodeficiency or those who have undergone organ/bone marrow transplantation;
• Patients deemed unsuitable to participate in this study by the investigator.

Trial design

562 participants in 2 patient groups

HAIC-group

Description:

HAIC combined with ICIs and TKIs

TACE-group

Description:

TACE combined with ICIs and TKIs