NCT04213118

Brief Summary

A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(HCC) patients at high risk of post surgery recurrence.

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
30

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2020

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

November 1, 2022

Enrollment Period

2.8 years

First QC Date

December 25, 2019

Last Update Submit

January 12, 2023

Conditions

Hepatocellular CarcinomaTACEAnlotinib

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    The period from resection surgery to recurrence of HCC

    From randomization to recurrence of HCC or death (up to 1year)

Secondary Outcomes (3)

  • 1-year DFS Rate

    From randomization to recurrence of HCC or death (up to 1year)

  • Time to recurrence

    From randomization to recurrence of HCC(up to 1year)

  • Incidence of Treatment-Emergent Adverse Events Safety and Tolerability

    Up to 30 day safety follow-up visit

Study Arms (1)

Group A

EXPERIMENTAL

Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.

Drug: Anlotinib HydrochlorideProcedure: TACE

Interventions

Anlotinib HydrochlorideDRUG

Anlotinib 12mg QD PO d1-14, 21 days per cycle.

Group A
TACEPROCEDURE

TACE first, followed by anlotinib within day4（+/-1days）

Group A

Eligibility Criteria

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

You may qualify if:

  • Patients participate in the study voluntarily and sign informed consent with good compliance.
  • After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and \< 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ).
  • Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP \> 400μg/L.
  • TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy.
  • ≥ 18 and ≤ 75 years of age.
  • ECOG performance status of 0-1.
  • liver function child-Pugh class A or B (≤7 points).
  • Except for hepatectomy, no previous tumor-related treatment was received, and the remaining liver was assessed to have good liver function.

You may not qualify if:

  • Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (\>10 mm)in baseline data or in TACE.
  • Patients with absolute contraindications to TACE.
  • Patients with HCV infection.
  • Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed.
  • Pregnant or lactating women.
  • Patients with mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Hanzhong Central Hospital

Hanzhong, Shaanxi, 723000, China

Location

Tangdu Hospital of The Fourth Military Medical University

Xi'an, Shaanxi, 710000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Related Publications (1)

  • Wang Z, Zhang L, Zheng X, Zhang D, Yang X, Xu K, Tao J, Song X, Ma J, Wu Z. Adjuvant anlotinib plus TACE in hepatocellular carcinoma with postoperative high-risk recurrence: a single-arm, multi-center, phase II study. Clin Transl Oncol. 2026 Jan 3. doi: 10.1007/s12094-025-04160-0. Online ahead of print.

    PMID: 41484570DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zheng Wu, PhD

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

April 23, 2020

Primary Completion

February 1, 2023

Study Completion

September 1, 2023

Last Updated

January 17, 2023

Record last verified: 2022-11

Locations

CN(4)