HAIC Compared With TACE in Huge Hepatocellular Carcinoma

March 21, 2025 updated by: Zhou Qunfang, Sun Yat-sen University

Hepatic Arterial Infusion Chemotherapy Compared With Transcatheter Arterial Chemoembolizationin Intermediate-advanced Huge Hepatocellular Carcinoma: a Multicenter Retrospective Study

This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
664

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Feng Duan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This study is a multicenter, observational real-world study to compare the efficacy of HAIC with TACE in advancedhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy . This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC and TACE in huge HCC therapy.

Description

Inclusion Criteria:

  1. Clinical diagnosis of primary HCC.
  2. Age between 18 and 75 years;
  3. The maximum tumor size ≥10 cm;
  4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
  5. limited metastases (≤5).
  6. Child-Pugh class A or B;
  7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
  8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
  9. Prothrombin time ≤18s or international normalized ratio < 1.7.

Exclusion Criteria:

  1. recurrent HCC;
  2. Extrahepatic metastasis >5;
  3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
  4. Serious medical comorbidities.
  5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  6. Eastern Cooperative Group performance status (ECOG) score of ≥2;
  7. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  8. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TACE
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then conventional TACE or drug-eluting TACE was used.
Procedure: TACE
TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels.
HAIC
HIAC was conducted with hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 3-4 weeks.
Procedure: HAIC
HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 6 months
ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 24 months
OS is the length of time from the date of inclusion until death from any cause.
24 months
Progression-Free-Survival
Time Frame: 12 months
Progression was defined as progressive disease by independent radiologic review
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese PLA General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Feng Duan, MD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Liver Projiect 13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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