Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339424
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Investigation of Antitumor Immune Response in Patients With Unresectable Hepatocellular Carcinoma Undergoing Photon Radiotherapy Combined With Atezolizumab and Bevacizumab
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:
PhotonAB
Brief Summary:
Atezolizumab anti-programmed death-ligand 1 anti-PD-L1 in conjunction with bevacizumab anti-vascular endothelial growth factor anti-VEGF has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma HCC Despite an improved objective response rate ORR of 27 the majority of patients face HCC progression and liver failure Finn et al N Engl J Med 2020 Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes
Radiation treatment RT is highly efficacious in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC Importantly a recent retrospective cohort described that RT combined with atezolizumab plus bevacizumab was associated with favorable median overall survival of 161 months Manzar et al Cancers 2022 Our preclinical study Hsieh et al Science Immunology 2022 revealed that RT combined with PD-L1PD-1 blockade induces immunogenic cell death and tumor antigen cross-presentation in antigen-presenting cells thereby potentiating the systemic antitumor T cell responses in murine tumor models However whether the combinatorial therapy with RT atezolizumab and bevacizumab can trigger synergistic antitumor effects and systemic immune mobilization has not yet been validated in clinical trials for unresectable HCC
Both atezolizumabbevacizumab and X-ray RT are approved treatment methods for unresectable HCC by the US and Taiwan Food and Drug Administration FDA The present phase II non-randomized trial aims to prospectively document the therapeutic efficacy safety and immunological responses in patients with unresectable HCC treated with atezolizumabbevacizumab combined with conventional photon radiotherapy
Radiation treatment RT is highly efficacious in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC Importantly a recent retrospective cohort described that RT combined with atezolizumab plus bevacizumab was associated with favorable median overall survival of 161 months Manzar et al Cancers 2022 Our preclinical study Hsieh et al Science Immunology 2022 revealed that RT combined with PD-L1PD-1 blockade induces immunogenic cell death and tumor antigen cross-presentation in antigen-presenting cells thereby potentiating the systemic antitumor T cell responses in murine tumor models However whether the combinatorial therapy with RT atezolizumab and bevacizumab can trigger synergistic antitumor effects and systemic immune mobilization has not yet been validated in clinical trials for unresectable HCC
Both atezolizumabbevacizumab and X-ray RT are approved treatment methods for unresectable HCC by the US and Taiwan Food and Drug Administration FDA The present phase II non-randomized trial aims to prospectively document the therapeutic efficacy safety and immunological responses in patients with unresectable HCC treated with atezolizumabbevacizumab combined with conventional photon radiotherapy
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?:
None