Hepatocellular Carcinoma (HCC)NCT07449065
CECT Features of MVI Predict Response to TACE Plus TKI in Intermediate-stage HCC
An observational study of Hepatocellular Carcinoma (HCC) and Transarterial Chemoembolization, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Transarterial Chemoembolization, Microvascular Invasion (MVI)
- What is being tested?
- TKI and TACE
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate-stage HCC treated with TACE with/without TKI
Inclusion Criteria:(1) age 18-75 years; (2) primary intermediate-stage HCC diagnosed according to the European Association for the Study of the Liver/American Association for the Study of Liver Diseases criteria; (3) pretreatment CECT showing two to three lesions, with at least one >3 cm, or more than three lesions of any size, without macrovascular invasion or extrahepatic metastasis; all lesions measurable per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria; (4) Child¬-Pugh class A or B; (5) Eastern Cooperative Oncology Group performance status score of 0; (6) adequate hematologic and renal function (neutrophils ≥1.5×109/L, platelets ≥50×109/L, hemoglobin ≥90 g/L, serum albumin ≥30 g/L, total bilirubin ≤50 µmol/L, creatinine <1.5× upper limit of normal); and (7) first-line local treatment with TACE, with or without sorafenib or lenvatinib.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Contrast-enhanced Computed Tomography Features of Microvascular Invasion Predict Response to Transarterial Chemoembolization Plus Tyrosine Kinase Inhibitor in Intermediate-stage Hepatocellular Carcinoma
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.
Read the detailed description
Patients who received TACE plus TKIs were compared with those who received TACE alone. Radiographic MVI status was assessed using CT-based radiomics features. The primary outcome is overall survival. Secondary outcomes include time to progression, objective response rate, and safety. The study seeks to determine whether radiographic MVI can serve as a predictive marker to guide the selection of patients who may benefit from combination therapy.
- Conditions
- Hepatocellular Carcinoma (HCC), Transarterial Chemoembolization, Microvascular Invasion (MVI), Tyrosine Kinase Inhibitors
- Being tested
- TKI, TACE
- Keywords
- HCC, TACE, MVI, TKI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
TACEProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TKI; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Time interval 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
Measured: 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
Defined as the proportion of patients achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to mRECIST criteria.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Jun 2018
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenzhe Fan, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449065
- Sponsor's protocol ID
- [2024]504
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Computed Tomography Features of Microvascular Invasion Predict Response to Transarterial Chemoembolization Plus Tyrosine Kinase Inhibitor in Intermediate-stage Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07449065
- Acronym / sponsor ID
- [2024]504
- Conditions
- Hepatocellular Carcinoma (HCC), Transarterial Chemoembolization, Microvascular Invasion (MVI), Tyrosine Kinase Inhibitors
- Keywords
- HCC, TACE, MVI, TKI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who received TACE plus TKIs were compared with those who received TACE alone. Radiographic MVI status was assessed using CT-based radiomics features. The primary outcome is overall survival. Secondary outcomes include time to progression, objective response rate, and safety. The study seeks to determine whether radiographic MVI can serve as a predictive marker to guide the selection of patients who may benefit from combination therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE group | – | Procedure: TACEPatients 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. |
| TACE-TKI group | – | Drug: TKI, Procedure: TACEPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate-stage HCC treated with TACE with/without TKI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKItyrosine 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. | Drug | TACE-TKI group |
| TACETACE 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). | Procedure or surgery | TACE group, TACE-TKI group |
Primary outcome
Overall survival
Time frame: From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months
Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months
2 secondary outcomes
Progression-free survival
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Transarterial Chemoembolization, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.