NCT07449065

Brief Summary

This retrospective multicenter study aims to evaluate whether radiographic microvascular invasion (MVI) status can predict treatment response in patients with intermediate-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) combined with tyrosine kinase inhibitors (TKIs) versus TACE alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2018

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

7.4 years

First QC Date

February 1, 2026

Last Update Submit

March 3, 2026

Conditions

Hepatocellular Carcinoma (HCC)Transarterial ChemoembolizationMicrovascular Invasion (MVI)Tyrosine Kinase Inhibitors

Keywords

HCCTACEMVITKI

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

    From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (2)

  • Progression-free survival

    From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  • Tumor response

    From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (2)

TACE group

Patients with intermediate-stage hepatocellular carcinoma who received TACE monotherapy. TACE procedures included conventional TACE and drug-eluting bead TACE, performed by experienced interventional radiologists. Conventional TACE involved infusion of a solution containing doxorubicin (75 mg) or epirubicin (50 mg) mixed with lipiodol, followed by embolization with gelatin sponge or polyvinyl alcohol foam particles. Drug-eluting bead TACE used DC Bead or Calispheres microspheres (100-300 or 300-500 μm) loaded with doxorubicin (75 mg) or epirubicin (50 mg). The endpoint of primary chemoembolization was complete HCC devascularization as observed on angiograms.

Procedure: TACE

TACE-TKI group

Patients with intermediate-stage hepatocellular carcinoma who received transarterial chemoembolization (TACE) combined with tyrosine kinase inhibitors (TKIs). TACE procedures included conventional TACE and drug-eluting bead TACE, performed by experienced interventional radiologists. Conventional TACE involved infusion of a solution containing doxorubicin (75 mg) or epirubicin (50 mg) mixed with lipiodol, followed by embolization with gelatin sponge or polyvinyl alcohol foam particles. Drug-eluting bead TACE used DC Bead or Calispheres microspheres (100-300 or 300-500 μm) loaded with doxorubicin (75 mg) or epirubicin (50 mg). TKI treatment included sorafenib (administered orally 400 mg twice daily) or lenvatinib (administered orally 8 mg/day for patients \<60 kg or 12 mg/day for patients ≥60 kg), with dose adjustments or interruptions based on treatment-related toxicities.

Drug: TKIProcedure: TACE

Interventions

TKIDRUG

tyrosine kinase TKI treatment included sorafenib (administered orally 400 mg twice daily) or lenvatinib (administered orally 8 mg/day for patients \<60 kg or 12 mg/day for patients ≥60 kg), with dose adjustments or interruptions based on treatment-related toxicities.

TACE-TKI group
TACEPROCEDURE

TACE procedures included conventional TACE and drug-eluting bead TACE, performed by experienced interventional radiologists. Conventional TACE involved infusion of a solution containing doxorubicin (75 mg) or epirubicin (50 mg) mixed with lipiodol, followed by embolization with gelatin sponge or polyvinyl alcohol foam particles. Drug-eluting bead TACE used DC Bead or Calispheres microspheres (100-300 or 300-500 μm) loaded with doxorubicin (75 mg) or epirubicin (50 mg).

TACE groupTACE-TKI group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with intermediate-stage HCC treated with TACE with/without TKI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 1, 2026

First Posted

March 4, 2026

Study Start

June 1, 2018

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

CN(1)