NCT05718492

A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antiangiogenic Agents

A Study of the Application of Hepatic Arterial Infusion in Advanced Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors and Antiangiogenic Agents

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a certain period of time, but more than half of the patients are still insensitive to the treatment. There is no evidence-based basis for second-line treatment after the progression of the disease.In view of the effectiveness of Hepatic arterial infusion (HAIC) in the first-line treatment of HCC in the Chinese population, this study intends to launch a prospective intervention study to explore the efficacy and safety of HAIC treatment in patients with advanced HCC after the failure of ICIs and antiangiogenic agents combination therapy, and to provide high-level evidence for optimizing the second-line treatment of advanced HCC in the future.

Detailed description

Each patient received an artery catheter procedure guided by digital subtraction angiography. Then, the FOLFOX (oxaliplatin 130 mg/m\^2, leucovorin 200 mg/m\^2, fluorouracil 400 mg/m\^2, and fluorouracil 2,400 mg/m\^2) regimen was sequentially infused through the catheter every cycle (3 weeks).A maximum of 4-6 courses of continuous hepatic artery infusion chemotherapy were received.If the patient has extrahepatic metastasis at baseline, ICIs should be used as a systemic treatment according to the severity of the disease. The drug type and treatment protocol of ICIs should be based on the most advanced treatment progress in the world.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	digital subtraction angiography.	Each patient received an artery catheter procedure guided by digital subtraction angiography.
DRUG	FOLFOX (oxaliplatin , leucovorin , fluorouracil , and fluorouracil )	Hepatic artery infusion chemotherapy. The FOLFOX (oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, fluorouracil 400 mg/m2, and fluorouracil 2,400 mg/m2) regimen was sequentially infused through the catheter every cycle (3 weeks).

Timeline

• Start date: 2022-10-18
• Primary completion: 2025-10-18
• Completion: 2026-10-18
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: China