A Phase 2 interventional study of Lenvatinib and TACE in Hepatocellular Carcinoma, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-24.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 54 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have received TACE or other local treatment for liver cancer (except bridged liver transplantation).
Drug: Lenvatinib · Procedure: TACE
Intervention Description：lenvatinib will be administered daily (for patients \<60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Also known as: Lenvatinib treatment
Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.
Also known as: Transcatheter arterial chemoembolization
Time to progression（TTP）
The time from the beginning of randomization to the tumor progression of the patient
Time frame: 2 years
Objective remission rate（ORR）
ORR according to modified RECIST for Hepatocellular Carcinoma
Time frame: 2 years
Adverse Events
Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)
Time frame: 2 years
Overall survival
the survival time after randomization
Time frame: 5 years
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital