A Phase 3 interventional study of TAI combine lenvatinib and Lenvatinib in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 206 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
TAI combine lenvatinib
Combination Product: TAI combine lenvatinib
lenvatinib only
Drug: Lenvatinib
TAI combine lenvatinib
lenvatinib only
OS
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
PFS
progression-free survival
Time frame: From date of randomization until the date of progress from any cause, assessed up to 60 months
ORR
object response rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
DCR
disease control rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University