HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

NCT ID: NCT03775395

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2021-12-01

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with lenvatinib combined with HAIC in patients with advanced hepatocellular carcinoma (HCC)

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HAIC plus Lenvatinib

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

12 mg (or 8 mg) once daily (QD) oral dosing.

Hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

HAIC plus Sorafenib

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

400mg BID daily oral dosing

Hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Interventions

Lenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing.

Intervention Type: DRUG

Sorafenib

400mg BID daily oral dosing

Intervention Type: DRUG

Hepatic arterial infusion chemotherapy

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
• Barcelona clinic liver cancer-stage C
• Eastern Cooperative Oncology Group performance status of 0 to 2
• with no previous treatment
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• The following laboratory parameters:
• Platelet count ≥ 75,000/μL
• Hemoglobin ≥ 8.5 g/dL
• Total bilirubin ≤ 30mmol/L
• Serum albumin ≥ 30 g/L
• ASL and AST ≤ 5 x upper limit of normal
• Serum creatinine ≤ 1.5 x upper limit of normal
• INR ≤ 1.5 or PT/APTT within normal limits
• Absolute neutrophil count (ANC) >1,500/mm3
• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known central nervous system tumors including metastatic brain disease

• 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

Shi Ming

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Shi, MD

Role: CONTACT

shiming@sysucc.org.cn

+862087343938

Facility Contacts

Ming Shi, MD

Role: primary

shiming@mail.sysu.edu.cn

8620-87343115

Other Identifiers

HCC-S055

Identifier Type: -

Identifier Source: org_study_id