Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Lenvatinib, PD-1 Antibody, TACE
Brief summary
The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria
Detailed description
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with hepatocellular carcinoma staged BCLC A/B especially for those with tumor beyond up-to-seven criteria. Recently, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus PD-1 antibody in intermediate-stage HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of lenvatinib combined with PD-1 antibody over TACE.
Interventions
DRUGLenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
DRUGPD-1 antibody
3mg/kg intravenously every 2 weeks
PROCEDURETACE
A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. TACE Drug Protocol were injected.
lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)
Sponsors
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. * Barcelona clinic liver cancer-stage B * Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor \[in cm\] and the number of tumors) * Eastern Cooperative Oncology Group performance status of 0 to 1 * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy. * The following laboratory parameters: Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 • Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion criteria
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | 24 months |
| Adverse Events | 24 months |
| Progression free survival | 24 months |
Countries
China
Outcome results
None listed