Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04945720
Status:
UNKNOWN
Last Update Posted:
2023-03-22
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)ćefficacy 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.
Detailed Description:
Femoral artery puncture and catheterization were performed in every cycle of treatment,a micro-catheter was inserted and located in feeding hepatic artery. The therapeutic scheme was modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs were given by HAI.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).Treatment was repeated every 3 weeks and continued until intrahepatic lesions progression or unacceptable toxicity.Enhanced CT or MRI was performed every 6 weeks after treatment begins. Routine follow-up intervals were 2-4 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: