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

NCT ID: NCT04961918

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-13
• Study Completion Date: 2023-07-13

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Rong-ping Guo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaohua Li, M.D.

Role: CONTACT

lishaoh@sysucc.org.cn

+8615088064187

Facility Contacts

Rong-Ping Guo, M.D.

Role: primary

guorp@sysucc.org.cn

00862087342266

Wei Wei, Ph.D. M.D.

Role: backup

weiwei@sysucc.org.cn

00862087343790

Other Identifiers

HILL-001

Identifier Type: -

Identifier Source: org_study_id