The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)
1 other identifier
interventional
206
1 country
1
Brief Summary
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hepatocellular-carcinoma
Started Jan 2018
Typical duration for phase_3 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 10, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 13, 2019
January 1, 2019
5 years
August 10, 2019
August 12, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
OS
overall survival
From date of randomization until the date of death from any cause, assessed up to 60 months
PFS
progression-free survival
From date of randomization until the date of progress from any cause, assessed up to 60 months
Secondary Outcomes (2)
ORR
From date of randomization until the date of death from any cause, assessed up to 60 months
DCR
From date of randomization until the date of death from any cause, assessed up to 60 months
Study Arms (2)
TAI+lenvatinib group
EXPERIMENTALTAI combine lenvatinib
lenvatinib group
ACTIVE COMPARATORlenvatinib only
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 10, 2019
First Posted
August 13, 2019
Study Start
January 1, 2018
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
August 13, 2019
Record last verified: 2019-01