NCT06631326

HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors as First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Target Trial Emulation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 244 (actual)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Conditions

• HCC - Hepatocellular Carcinoma
• Hepatic Arterial Infusion Chemotherapy
• BCLC Stage C Hepatocellular Carcinoma
• Lenvatinib
• PD-1 Inhibitors

Interventions

Type	Name	Description
PROCEDURE	hepatic artery infusion chemotherapy	Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
DRUG	Lenvatinib + PD-1 monoclonal antibody	PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-10-22
• Completion: 2025-10-22
• First posted: 2024-10-08
• Last updated: 2026-01-27

Locations

1 site across 1 country: China