Chinese PLA hospital
Beijing, Beijing Municipality, 100853, China
Location status: Recruiting
Location contact
Feng Duan, MD
PRINCIPAL_INVESTIGATOR
MD
CONTACT
Qunfang Zhou, Md
CONTACT
NCT Number: NCT06323382
Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Beijing, Beijing Municipality, 100853, China
Location status: Recruiting
Feng Duan, MD
PRINCIPAL_INVESTIGATOR
MD
CONTACT
Qunfang Zhou, Md
CONTACT
This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 inhibitor as standard of care in hopes of answering key clinical questions.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TACE procedure The decision to utilize transarterial artery chemoembolization (TACE) was performed through the tumor-feeding artery. The embolization emulsion was a mixture of Epirubicin 30-60 mg, Lobaplatin 30-50 mg, and Lipiodol 10-30 ml, and it was infused into tumor-feeding arteries via a 2.7/2.8 Fr micro-catheter.
HAIC procedure Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.
Other names: TACE/HAIC
15mg/kg or 7.5mg/kg intravenously every 3 weeks
1200mg intravenously every 3 weeks
200mg intravenously every 3 weeks
220mg intravenously every 3 weeks
200mg intravenously every 3 weeks
200mg intravenously every 3 weeks
Time frame: 12 months
Progression was defined as progressive disease by independent radiologic review
Time frame: 24 months
OS is the length of time from the date of inclusion until death from any cause.
Time frame: 12 months
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
Time frame: 24 months
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations
Contact information is provided by the study sponsor or research team.
Feng Duan, MD
CONTACT
Qunfang Zhou, MD
CONTACT
Sun Yat-sen University
Other
Efficacy of Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma: a Multicenter, Observational, Real-world Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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