Advanced Hepatocellular Carcinoma
Conditions
Keywords
Lenvatinib, Transarterial chemoembolisation
Brief summary
This trial is is an open label, multicenter, randomized controlled phase 3 clinical trial. The purpose is to compare the efficacy and safety of lenvatinib plus TACE with lenvatinib alone for advanced HCC patients.
Interventions
PROCEDURETACE
TACE will be performed one day after oral administration of lenvatinib. TACE with either cTACE or DEB-TACE can be used, depending on the condition of each center.
DRUGLenvatinib
Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients \<60kg, and 12 mg qd for patients \>60kg)
Sponsors
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
1. Age 18-75 years old; 2. Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment; 3. There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus or with extrahepatic metastasis; 4. ECOG score 0-1; 5. Child-Pugh class A; 6. Expected survival time ≥ 3 months; 7. Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal
Exclusion criteria
1. Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct; 2. Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices; 3. There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis; 4. Brain metastases; 5. Hypersensitivity to intravenous contrast agents; 6. Pregnant or lactating women or subjects with family planning within two years; 7. With HIV, syphilis infection; 8. Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment; 9. Allogeneic organ transplant recipients; 10. Severe dysfunction of heart and kidney or other organs; 11. Active severe infection \> grade 2 (NCI-CTC version 4); 12. Suffering from mental and psychological diseases may affect informed consent; 13. Unable to take oral medication; 14. Participated in other drug clinical trials within 12 months before enrollment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | two years | Defined as the time from randomization to death for any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | two years | Defined as the time from randomization to disease progression. |
Countries
China
Contacts
Primary ContactMing Kuang, PhD
Outcome results
None listed