Clinical Research Directory
Browse clinical research sites, groups, and studies.
TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma
Sponsor: Tongji Hospital
Summary
Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or those complicated with portal vein tumor thrombosis (PVTT). Hepatic arterial infusion chemotherapy (HAIC), as an alternative locoregional therapy, has demonstrated advantages in treating these refractory cases. Therefore, this study innovatively designs a prospective cohort study to conduct a comparison of the two triple-combination regimens-"HAIC plus PD-1 inhibitor and lenvatinib" versus "TACE plus PD-1 inhibitor and lenvatinib"-in terms of real-world efficacy and safety, with a focus on enrolling patients who are likely to have suboptimal responses to TACE. This research aims to provide high-level evidence for selecting the optimal combined locoregional strategy for uHCC patients, thereby directly guiding clinical practice and potentially advancing the optimization of treatment strategies and personalized precision medicine to improve patient survival outcomes.
Official title: TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective, Observational Cohort Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
364
Start Date
2026-01-31
Completion Date
2028-12-31
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
TACE
TACE blocks the tumor's blood supply while delivering high concentrations of chemotherapy agents directly into the hepatic artery. Patients received on-demand TACE until the end of the study or tumor progression.
HAIC
HAIC involves the continuous infusion of high-dose chemotherapy into the hepatic artery via an indwelling catheter, enabling prolonged and deep tumor exposure. Patients received on-demand HAIC until the end of the study or tumor progression.
PD-1inhibitors
200mg was given intravenously every three weeks.
Lenvatinib
The dose is determined by body weight, body weight greater than or equal to 60kg, 12mg, oral; Less than 60kg, 8mg, orally.