HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Hepatic Artery Infusion Chemotherapy Plus Lenvatinib vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03775395
• Other study ID #: HCC-S055
• Status: Recruiting
• Phase: Phase 3
• Start date: December 12, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: Ming Shi, MD
• Phone: +862087343938
• Email: shiming[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
• Sorafenib
400mg BID daily oral dosing

Procedure:
• Hepatic arterial infusion chemotherapy
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival	Time Frame: 12 months
Secondary	Time to progression	Time to progression	Time Frame: 12 months
Secondary	Adverse Events		[Time Frame: 30 days]
Secondary	Progression Free Survival (PFS)		Time Frame: 12 months