NCT06375317

HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure

A Single-center, Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Yehua Shen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value.

Detailed description

This is A Single-center, Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined with PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure. In clinical practice, second-line liver cancer treatment still mainly relies on single-agent therapy, which may not provide additional clinical benefits for patients. On one hand, a real-world multicenter study published by ESMO in 2023 showed that the combination of ICIs and TKIs may still have potential efficacy in patients who progress after first-line targeted therapy for advanced liver cancer. Secondly, the combination of targeted therapy and local hepatic arterial infusion chemotherapy (HAIC) may provide a new opportunity for patients with advanced liver cancer who progress after targeted therapy. On the other hand, unlike PD-1 inhibitors, PD-L1 inhibitors can block the binding ability of PD-L1 with B7.1 on the surface of T cells, which is advantageous for comprehensive T cell activation. At the same time, PD-L1 monoclonal antibody only blocks the binding of PD-L1 with PD-1, preserving the function of PD-L2 and avoiding side effects such as interstitial lung disease (ILD), thus having better safety. Therefore, this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy.

Conditions

• HCC - Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets	PD-L1 injection: 20 mg/kg, administered every 3 weeks (Q3W). Regorafenib: 80 mg, orally, once daily (qd), continuously for 14 days per cycle, followed by a 7-day rest period, administered every 3 weeks (Q3W). FOLFOX regimen: Oxaliplatin 85 mg/m2, Calcium folinate 400 mg/m2, Fluorouracil 400 mg/m2 as an IV bolus, followed by Fluorouracil 1200 mg/m2 infusion over 23 hours, administered every 3 weeks (Q3W) for a total of 6 cycles. The above doses are recommended doses.

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-04-30
• Completion: 2026-10-30
• First posted: 2024-04-19
• Last updated: 2024-04-19