The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC)

Sun Yat-sen University

Status and phase

Unknown

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)

Study type

Interventional

Funder types

Other

Identifiers

HILL-001

Details and patient eligibility

About

To evaluate the efficacy of HAIC combine Lenvatinib and Durvalumab (HILL) in advanced HCC.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;