Hepatocellular Carcinoma
Conditions
Brief summary
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma
Interventions
COMBINATION_PRODUCTTAI combine lenvatinib
TAI combine lenvatinib
DRUGLenvatinib
lenvatinib only
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
older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent
Exclusion criteria
cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of randomization until the date of death from any cause, assessed up to 60 months | overall survival |
| PFS | From date of randomization until the date of progress from any cause, assessed up to 60 months | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From date of randomization until the date of death from any cause, assessed up to 60 months | object response rate |
| DCR | From date of randomization until the date of death from any cause, assessed up to 60 months | disease control rate |
Countries
China
Outcome results
None listed