Hepatocellular Carcinoma
Conditions
Brief summary
To evaluate the efficacy of HAIC combine Lenvatinib and Durvalumab (HILL) in advanced HCC.
Interventions
PROCEDUREHepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)
Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; cannot accepted hepatectomy; 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 HAIC or lenvatinib or durvalumab; 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 |
|---|---|---|
| PFS | From date of randomization until the date of progression, assessed up to 36 months | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From date of randomization until the date of death, assessed up to 36 months | objective response rate |
| DCR | From date of randomization until the date of death, assessed up to 36 months | disease control rate |
| OS | From date of randomization until the date of death from any cause, assessed up to 36 months | overall survival |
Countries
China
Contacts
Primary ContactShaohua Li, M.D.
Outcome results
None listed