The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Combination Product: TAI combine lenvatinib; Drug: Lenvatinib

• Registration Number: NCT04053985
• Lead Sponsor: Sun Yat-sen University

Brief Summary

evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-01
• Study First Submitted: 2019-08-10
• Study First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Study First Posted: 2019-08-13
• Last Update Posted: 2019-08-13
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; 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 TAI or surgery; 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAI+lenvatinib group	TAI combine lenvatinib	TAI combine lenvatinib
lenvatinib group	Lenvatinib	lenvatinib only

Primary Outcome Measures

Name	Time	Method
OS	From date of randomization until the date of death from any cause, assessed up to 60 months	overall survival
PFS	From date of randomization until the date of progress from any cause, assessed up to 60 months	progression-free survival

Secondary Outcome Measures

Name	Time	Method
ORR	From date of randomization until the date of death from any cause, assessed up to 60 months	object response rate
DCR	From date of randomization until the date of death from any cause, assessed up to 60 months	disease control rate

Trial Locations

Locations (1)

SUN YAT-SEN University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China