NCT05573282

Observation Study of Sequential Regorafenib Plus ICIs After HAIC for Advanced Hepatocellular Carcinoma

Observation Study of Sequential Regorafenib Combined With Immunocheckpoint Inhibitors After Hepatic Artery Infusion Chemotherapy for Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hepatic artery infusion chemotherapy (HAIC) has shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC). Some patients can be converted to loco-regional therapies after 4-6 cycles of HAIC treatment. But most of these patients still need to concern the sequential treatment after standard HAIC treatment (4-6 cycles). Combination of anti-angiogenic molecular targeted therapy and immune checkpoint inhibitor (ICI) therapy has shown promising antitumor activity in HCC. Regorafenib is one of the standard second-line systemic therapy for advanced HCC. In this study, we will evaluate the efficacy and safety of sequential therapies of Regorafenib plus ICI in patients with advanced HCC who have completed 4-6 cycles of HAIC.

Detailed description

The standard procedure for HAIC is that femoral artery puncture and catheterization are performed in every cycle of treatment, a micro-catheter is inserted and located in feeding hepatic artery. The therapeutic scheme is modified FOLFOX6 regimens including oxaliplatin, leucovorin and Fluorouracil. All chemo-drugs are given by HAI. A total of 4-6 cycles of HAIC are performed and the treated efficacy is evaluated. Patient who is not suitable for loco-regional therapies after 4-6cycles of HAIC becomes to the candidate of sequential therapies of regorafenib plus ICIs. The regorafenib 80 mg/day was uses in sequential treatment. And ICIs were used intravenously at the standard dose. Patients received sequential treatment will begin no earlier than 30 days following the last HAIC procedure.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	Regorafenib combine with ICIs	Regorafenib: 80mg/day, PO, QD, d1～d21, Q4W ICIs: 200mg/day, IV, d1,Q3W

Timeline

• Start date: 2022-10-16
• Primary completion: 2025-06-01
• Completion: 2026-01-01
• First posted: 2022-10-10
• Last updated: 2022-10-18

Locations

2 sites across 1 country: China