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NCT Number: NCT06190665

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEB-TACE with visualable microspheres

Device

Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres

DEB-TACE with PVA microspheres

Device

Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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%.

  3. 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?

  4. 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.

  5. 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.

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hai-Dong Zhu

CONTACT

[email protected]

+86-25-83272121

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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