Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-02 @ 12:49 PM
Study NCT ID:
NCT06485466
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
Sponsor:
Guohui Xu
Organization:
Study Overview
Official Title:
Transarterial Chemoembolization Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma : a Randomised , Open Label, Multicenter Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC.
The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.
This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.
This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: