Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT05493332
Status:
UNKNOWN
Last Update Posted:
2022-08-18
First Post:
2022-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Study Overview
Official Title:
A Prospective, Single-armed, Multicentric, Explorative Phase II Clinical Research of Conversional Therapy With Combination of Hepatic Arterial Infusion Chemotherapy and Donafenib and Toripalimab for Unresectable Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_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:
This is a prospective, single-armed, multicentric, explorative phase II clinical research of conversional therapy with combination of hepatic arterial infusion chemotherapy(HAIC), Donafenib Tosilate and Toripalimab for unresectable hepatocellular carcinoma.
Detailed Description:
Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. Currently, it is gradually used in the treatment of hepatocellular carcinoma (HCC) with good safety and high objective response rate. Immunotherapy combined with targeted and chemotherapy was well tolerated. At present, anti-programmed cell death protein-1(PD-1) antibody combined with chemotherapy and targeted therapy for advanced biliary tract tumors has initially shown good safety and encouraging efficacy, which is worthy of further exploration. Therefore, this study aims to evaluate the efficacy and safety of HAIC (FOLFOX) combined with Toripalimab and Donafenib Tosilate in unresectable HCC.
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?: