At a glance
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An Open Label Pilot Study to Evaluate Efficacy and Safety of Durvalumab(MEDI 4736) With Hepatic Artery Infusion Chemotherapy (HAIC) in the Chinese Advanced HCC Patients With Severe Portal Vein Tumor Thrombosis (PVTT)(Vp3 or Vp4) DurHope
In Brief
A Phase 2 clinical trial evaluating Hepatic artery infusion chemotherapy（HAIC） and Durvalumab for Hepatocellular Carcinoma. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Hepatic artery infusion chemotherapy (HAIC) and anti-programmed cell death protein-1ligand (PD-L1) immunotherapy have shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC), respectively. However, the combination of the two treatments has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy and safety in patients with advanced hepatocellular carcinoma (Ad-HCC) with portal vein embolism who are undergoing hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment combined with anti-PD-L1 immunotherapy (Durvalumab) by designing an open, single-arm phase II clinical study.
Study Details
Timeline
Interventions
hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment
Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose: Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).