Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454578
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
An Open-Label Single Arm Study to Evaluate the Efficacy and Safety of Adebrelimab Plus Apatinib as Adjuvant Therapy in Participants With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This is a single-center single-arm open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma HCC participants who are at high risk of recurrence after curative resection
Detailed Description:
Hepatocellular carcinoma HCC is a malignant tumor with high morbidity and mortality Surgical resection is the most important radical treatment However the recurrence rate is high especially in the participants with high risk of recurrence after curative resection
Adebelimumab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical It can specifically bind to PD-L1 molecules to block the PD-1PD-L1 pathway that leads to tumor immune tolerance reactivate the anti-tumor activity of the immune system and achieve the goal of treating tumors As of October 8 2021 adebelimumab has conducted several clinical studies in various malignant tumor fields and has shown good anti-tumor efficacy and controllable safety
Therefore the investigators plan to conduct a prospective clinical study targeting HCC participants at high risk of postoperative recurrence to demonstrate the efficacy and safety of postoperative adjuvant therapy with adebelimumab combined with apatinib This study has the potential to provide efficient new treatment options for participants which is of great significance for improving the survival rate and quality of life of liver cancer participants in general
A mid-term analysis will be conducted on the recurrence free survival rate and survival rate at 6 months after the enrollment of 30 participants
Adebelimumab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical It can specifically bind to PD-L1 molecules to block the PD-1PD-L1 pathway that leads to tumor immune tolerance reactivate the anti-tumor activity of the immune system and achieve the goal of treating tumors As of October 8 2021 adebelimumab has conducted several clinical studies in various malignant tumor fields and has shown good anti-tumor efficacy and controllable safety
Therefore the investigators plan to conduct a prospective clinical study targeting HCC participants at high risk of postoperative recurrence to demonstrate the efficacy and safety of postoperative adjuvant therapy with adebelimumab combined with apatinib This study has the potential to provide efficient new treatment options for participants which is of great significance for improving the survival rate and quality of life of liver cancer participants in general
A mid-term analysis will be conducted on the recurrence free survival rate and survival rate at 6 months after the enrollment of 30 participants
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?:
None