Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Neoadjuvant SBRT Combined With Lenvatinib and Pucotenlimab for Resectable Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Stereotactic Body Radiotherapy SBRT Combined With Lenvatinib and Pucotenlimab for Resectable Hepatocellular Carcinoma With Macrovascular Invasion A Single-arm Phase II Study
Status:
ACTIVE_NOT_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:
At the time of diagnosis the majority of hepatocellular carcinoma HCC patients are at the intermediate to advanced stages with a 50-70 incidence of macrovascular invasion including portal vein hepatic vein inferior vena cava or bile duct invasion Tyrosine kinase inhibitors TKI including lenvatinib and sorafenib or a combination of TKIs and immune therapy is one of the standard treatment options recommended by HCC guidelines However numerous retrospective studies have reported that for surgically resectable HCC with macrovascular invasion surgical resection yields better efficacy than non-surgical treatments including transarterial interventional therapies andor systemic therapies Nevertheless the postoperative recurrence rate remains exceedingly high exceeding 80 Therefore determining comprehensive approaches to enhance surgical radicality and reduce postoperative recurrence rates is a current research hotspot
Recent studies have found that neoadjuvant therapy including immunotherapy alone or in combination with TKI before surgery can reduce postoperative recurrence rates and extend survival rates Moreover SBRT combined with TKI and immunotherapy has a sensitizing effect particularly showing good sensitivity and control rates for vascular invasion
Thus this study aims to conduct a prospective single-arm phase II clinical trial targeting patients with surgically resectable HCC with macrovascular invasion The primary endpoints are objective response rate ORR and treatment completion rate to evaluate the efficacy and safety of the preoperative neoadjuvant therapy with the combination of SBRT lenvatinib and pucotenlimab an anti PD-1 drug The secondary endpoints include progression-free survival PFS overall survival OS incidence of adverse events pathological response rate and incidence of surgical complications to preliminarily evaluate the efficacy of the neoadjuvant therapy with this triple regimen
Recent studies have found that neoadjuvant therapy including immunotherapy alone or in combination with TKI before surgery can reduce postoperative recurrence rates and extend survival rates Moreover SBRT combined with TKI and immunotherapy has a sensitizing effect particularly showing good sensitivity and control rates for vascular invasion
Thus this study aims to conduct a prospective single-arm phase II clinical trial targeting patients with surgically resectable HCC with macrovascular invasion The primary endpoints are objective response rate ORR and treatment completion rate to evaluate the efficacy and safety of the preoperative neoadjuvant therapy with the combination of SBRT lenvatinib and pucotenlimab an anti PD-1 drug The secondary endpoints include progression-free survival PFS overall survival OS incidence of adverse events pathological response rate and incidence of surgical complications to preliminarily evaluate the efficacy of the neoadjuvant therapy with this triple regimen
Detailed Description:
None
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