NCT03838796

Brief Summary

The purpose of the study is to observe the effect of Lenvatinib Combined With TACE in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
297

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

3.5 years

First QC Date

February 11, 2019

Last Update Submit

July 29, 2022

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    the survival time after liver resection without tumor recurrence or metastasis

    2 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (2)

lenvatinib

ACTIVE COMPARATOR

use lenvatinib after liver resection in HCC patients

Drug: lenvatinib

lenvatinib and TACE

ACTIVE COMPARATOR

use lenvatinib and TACE after liver resection in HCC patients

Drug: lenvatinibProcedure: TACE

Interventions

lenvatinibDRUG

for patients \<60kg, lenvatinib 8mg bid po for patients \>60kg, lenvatinib 12mg bid po

Also known as: lenvatinib treatment
lenvatiniblenvatinib and TACE
TACEPROCEDURE

The patient underwent transfemoral hepatic artery angiography one month after surgery to observe whether there was tumor staining in the liver. If there was suspicious tumor staining, micro-catheter was superselected to the tumor blood vessel, the embolization agents and chemotherapy drugs were injected. If there was no tumor staining, a small amount of embolization agents were slowly injected into the artery.

Also known as: transcatheter arterial chemoembolization
lenvatinib and TACE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The characteristics of the treatment history:
  • No lenvatinib treatment history, no sorafenib allergies.
  • The characteristics of the tumor:
  • The pathological results is hepatocellular carcinoma.
  • Meet any of the following articles:
  • Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number≥3,Tumor size≥8cm,Tumor margin is not clear and no complete capsule.
  • With the embolus in Portal vein, hepatic vein or bile duct. Preoperative rupture or invasion the adjacent organs.
  • The characteristics of the patients:
  • The patient age was between 18-75. The American Society of Anesthesiologists(ASA）score was I-III. The Child-pugh score was A. Total bilirubin≤3.0 mg/dL, albumin≥28 g/L, AST, ALT, ALP≤5 times the upper limit of normal value.
  • Routine blood test: the neutrophil≥1.5×10\^9/L, Hb≥8.5g/L，PLT≥75×10\^9/L. The INR≤2.3. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points

You may not qualify if:

  • R1/2 or palliative rescted tumor
  • Pregnant or lactating women.
  • Patients with other malignant tumor.
  • Patients with mental illness.
  • Patients participated in other clinical trials in last three months.
  • Residual lesions showed by Postoperative digital subtraction angiography(DSA).
  • Postoperative patients treated with other targeted drugs, PD1 antibody and other immunotherapies, FOLFOX systemic chemotherapy, and HuaiErKeLi drug treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital

Shanghai, 200040, China

Location

Related Publications (5)

  • Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.

    PMID: 14667750RESULT

  • Sun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. doi: 10.1007/s00432-006-0091-y. Epub 2006 Mar 24.

    PMID: 16557381RESULT

  • Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.

    PMID: 29420221RESULT

  • Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

    PMID: 29433850RESULT

  • Chen JH, Lu L, Zhang XY, Xiang BD, Xu X, Li XC, Huang ZY, Wen TF, Luo LP, Huang J, Zhong JH, Liu ZK, Li CX, Long X, Zhu WW, Yang X, Wang CQ, Jia HL, Zhang JB, Zeng YY, Lu CD, Qin LX. Adjuvant lenvatinib in combination with transarterial chemoembolization for hepatocellular carcinoma patients with high risk of postoperative recurrence: A multicenter prospective cohort study. Hepatobiliary Pancreat Dis Int. 2025 Jun;24(3):277-285. doi: 10.1016/j.hbpd.2025.03.001. Epub 2025 Mar 26.

    PMID: 40187927DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Lunxiu Qin, MD

    Department of general surgery, Huashan hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the general surgery department, Huashan hospital

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 12, 2019

Study Start

January 3, 2019

Primary Completion

June 30, 2022

Study Completion

June 1, 2023

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)