DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

January 10, 2024 updated by: Gao-jun Teng, Zhongda Hospital

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial

This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for 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

This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.

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.
Interventional

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.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Yin-Hua Zou
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital，Southeast University
        • Contact:
          • Hai-Dong Zhu

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

No

Description

Inclusion Criteria:

  • CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
  • ECOG PS score of 0-2
  • With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
  • Agree to participate in this trial and voluntarily sign the informed consent form

Exclusion Criteria:

  • Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
  • With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months With sepsis or multiple organ dysfunction
  • Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine >2 mg/dL)
  • Significant reductions in white blood cells or platelets (white blood cells <3.0×10^9/L, platelets <50×10^9/L, hemoglobin<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by >3 seconds above the upper limit of normal)
  • With severe infection (>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
  • With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
  • Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
  • Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
  • Pregnant or lactating women
  • Patients who are participating in other trial(s)
  • Unsuitable for participation in this trial deemed by the researchers

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Visualable microspheres
DEB-TACE with visualable microspheres
Device: DEB-TACE with visualable microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
Active Comparator: PVA microspheres
DEB-TACE with polyvinyl alcohol microspheres
Device: DEB-TACE with PVA microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres

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
Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
Time Frame: 1 month after last TACE treatment
Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
1 month after last TACE treatment

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
Visualization score of embolic area
Time Frame: Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
Evaluation will be performed, based on CBCT images after the first TACE treatment, or CT plain images after the last TACE treatment as follow: 3 points: dense imaging (imaging area >75% of tumor area); 2 points: mixed imaging (imaging area 25%-75% of tumor area); 1 point: weak imaging (imaging area <25% of tumor area); 0 point: not visible (no imaging in the tumor area).
Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
Embolization success rate of target lesions
Time Frame: Immediately after each TACE treatment
Defined as the number of successful embolizations for the target lesions / the total number of participants ×100%.
Immediately after each TACE treatment
Disease control rate (DCR) for target lesions
Time Frame: 1 month after the first TACE treatment, and 3 months after the last TACE treatment
Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.
1 month after the first TACE treatment, and 3 months after the last TACE treatment
Objective response rate（ORR）
Time Frame: 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment
Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.
1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment
Number of TACE treatments for target lesions
Time Frame: 6 month since the last TACE treatment
Totel times of TACE treatments for all target lesions
6 month since the last TACE treatment
Equipment performance evaluation
Time Frame: From the begin to immediately after each TACE treatment
Includes,the visualization performance of the microspheres on the fluoroscopy or cone-beam CT imaging; whether the microspheres can be easy pushed and pass through the catheter smoothly; whether the micro-catheter will be blocked during the process of pushing and releasing?
From the begin to immediately after each TACE treatment

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.
Zhongda 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.
  • Principal Investigator: Gao-Jun Teng, Zhongda 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.
December 19, 2023

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.
December 31, 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 31, 2026

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).
December 19, 2023

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.
December 19, 2023

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.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

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.
January 12, 2024

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.
January 10, 2024

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.
January 1, 2024

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.
  • CHANCE 2305

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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