Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538935
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Open-label Two Arm Investigator-initiated Trail of Stereotactic Radiotherapy SBRT in Combination With an Anti-PD-L1 Inhibitor Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II Open-label Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular CarcinomaHCCThis study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC
Detailed Description:
This is an Open Two Arm Exploratory and Phase II Clinical Trial of SBRT Combined With Adbelimumab an Anti-PD-L1 Inhibitor and Apatinib in Patients With Hepatocellular CarcinomaHCC as Perioperative and Conversion Treatment we conduct this study in order to observe and evaluate the efficacy and safety of SBRT Combined With Adbelimumab and Apatinib in treatment of patients with HCC Primary Efficacy Endpoint Perioperative cohort-Pathological complete response Rate pCR Conversion cohort-Objective ResponseORR According to RECIST Version 11Secondary Efficacy EndpointsPerioperative cohort-Major pathologic response MPR Event-free survival EFS and Overall survival OS Conversion cohort-Radical R0 resection rateDisease control rate DCRProgression free survivalPFS and Overall survival OS Safety and tolerance will be evaluated by incidence severity and outcomes of AEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None