Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261125
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-08
Brief Title:
Combination of SBRT PD-L1 Inhibitor and Lenvatinib in Hepatocellular Carcinoma HSBRT2401
Sponsor:
Mian XI
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Efficacy and Safety of Stereotactic Body Radiotherapy Followed by Adebrelimab and Lenvatinib for Hepatocellular Carcinoma With Abdominal Lymph Node Metastases A Two-arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
HSBRT2401
Brief Summary:
Abdominal lymph node metastasis LNM is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma HCC Immunotherapy targeting the PD-1PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM but the outcome remains very poor with an objective response rate of 5 to 30 Previous studies have demonstrated that stereotactic body radiotherapy SBRT is an effective local treatment for HCC with abdominal LNM with a high response rate of 60 to 80 However intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients suggesting radiotherapy should be combined with systematic treatment Recently the combination of immunotherapy with SBRT has shown promising activity in HCC The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab an anti-PD-L1 antibody and lenvatinib in HCC patients with portal abdominal LNM
Detailed Description:
A total of 60 HCC patients 2 cohorts with abdominal LNM will be enrolled to receive SBRT followed by adebrelimab an anti-PD-L1 antibody and lenvatinib Arm A included the patients who previously had not received PD-1PD-L1 antibody and Arm B included the patients who had progressed after receiving PD-1PD-L1 antibody
Patients in both cohorts will receive stereotactic body radiotherapy SBRT using volumetric arc therapy The prescribed dose is 33-48 Gy in 6 fractions over 2 weeks Then all patients will receive lenvatinib 12 mgday for bodyweight 60 kg or 8 mgday for bodyweight 60 kg orally once daily in combination with adebrelimab 1200 mg every 3 weeks for up to 35 cycles The first course of adebrelimab will be given within 1 week after completion of SBRT
Patients in both cohorts will receive stereotactic body radiotherapy SBRT using volumetric arc therapy The prescribed dose is 33-48 Gy in 6 fractions over 2 weeks Then all patients will receive lenvatinib 12 mgday for bodyweight 60 kg or 8 mgday for bodyweight 60 kg orally once daily in combination with adebrelimab 1200 mg every 3 weeks for up to 35 cycles The first course of adebrelimab will be given within 1 week after completion of SBRT
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