HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Lenvatinib; Drug: Sorafenib; Procedure: Hepatic arterial infusion chemotherapy

• Registration Number: NCT03775395
• Lead Sponsor: Sun Yat-sen University

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-01
• Last Update Posted: 2019-01-03
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAIC plus Sorafenib	Hepatic arterial infusion chemotherapy	-
HAIC plus Lenvatinib	Hepatic arterial infusion chemotherapy	-
HAIC plus Lenvatinib	Lenvatinib	-
HAIC plus Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Overall survival	Time Frame: 12 months	Overall survival

Secondary Outcome Measures

Name	Time	Method
Time to progression	Time Frame: 12 months	Time to progression
Adverse Events	[Time Frame: 30 days]
Progression Free Survival (PFS)	Time Frame: 12 months

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China