Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
age between 18 and 75 years;
Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage).
Locoregional therapy include TACE or HAIC, locoregional combined with Bevacizumab and PD1/L1 inhibitor as firstline therapy; non-firstline therapy (previous use of any systemic therapy but intolerant or drug resistant).
Disqualifiers
Cholangiocellular carcinoma (ICC).
Patients without image information should be excluded;
The survival or patients less than 3 months.
Serious medical comorbidities.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Locoregional therapy
Procedure/SurgeryTACE 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.
Bevacizumab
Drug15mg/kg or 7.5mg/kg intravenously every 3 weeks
Atezolizumab
Drug1200mg intravenously every 3 weeks
Tislelizumab
Drug200mg intravenously every 3 weeks
Toripalimab
Drug220mg intravenously every 3 weeks
Sintilimab
Drug200mg intravenously every 3 weeks
Camrelizumab
Drug200mg intravenously every 3 weeks
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Progression-Free-Survival (PFS)
Progression was defined as progressive disease by independent radiologic review
Time frame
12 monthsSecondary outcomes
1
Overall survival (OS)
OS is the length of time from the date of inclusion until death from any cause.
Time frame
24 months2
Objective response rate (ORR)
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
12 months3
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov