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New bead therapy may improve liver cancer treatment after shunt procedure

NCT ID NCT07322848

Disease control Sponsor: First Affiliated Hospital, Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether drug-eluting bead chemoembolization (DEB-TACE) works better than conventional chemoembolization (cTACE) for liver cancer patients who have had a TIPS procedure to manage complications of cirrhosis. The study will enroll 206 participants and track survival, tumor response, and quality of life over 24 months. The goal is to find a safer and more effective treatment option for this challenging patient group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
drug-eluting beads loaded with epirubicin or doxorubicin
What this could lead to
If DEB-TACE proves better, it could become the preferred treatment for liver cancer patients who have had a TIPS procedure, offering better survival and fewer side effects.
What could go wrong
This is a mid-stage trial with 206 participants, so results may not apply to all patients. The altered blood flow after TIPS could still cause liver toxicity or limit effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 206 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. histologically or clinically confirmed primary hepatocellular carcinoma, beyond Milan criteria (single lesion \>5 cm OR ≥3 lesions with at least one ≥3 cm). At least one intrahepatic measurable lesion with tumor burden ≤50%, no distant metastasis. No prior antitumor therapy within 12 months before enrollment. 2. underwent TIPS procedure for secondary prevention of variceal bleeding or refractory ascites. Confirmed patent TIPS at 1-month follow-up with portosystemic blood flow visible throughout the shunt and Doppler velocity \> 60 cm/s. 3. child-Pugh class A or B. 4. estimated survival ≥3 months. 5. adequate organ function:Neutrophils ≥1.5 × 10⁹/L; Platelets ≥50 × 10⁹/L; Hemoglobin ≥90 g/L; Serum albumin ≥30 g/L; Bilirubin ≤50 μmol/L; AST/ALT ≤5 × upper limit of normal (ULN), ALP ≤4 × ULN; INR ≤2.3; Creatinine ≤1.5 × ULN. Exclusion Criteria: 1. diffuse hepatic infiltration, unassessable lesions on imaging, or tumor burden \>50%. 2. simultaneous portal vein branch tumor thrombus or main portal vein tumor thrombus. 3. underwent liver transplantation or antitumor therapy after TIPS placement. 4. contraindications to TACE (e.g., portosystemic shunt, hepatofugal blood flow, significant atherosclerosis). 5. presence of brain metastases. 6. Allergy to contrast agents. 7. pregnancy, breastfeeding, or planning pregnancy within 2 years. 8. co-infection with HIV or syphilis. 9. concurrent other malignancy or history of other malignancy within the past 5 years. 10. severe cardiac, renal, or other organ dysfunction. 11. active clinically severe infection \> Grade 2 (per NCI-CTC v5.0). 12. psychiatric/psychological conditions that may impair informed consent. 13. participation in other drug clinical trials within 12 months prior to enrollment.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CTACE Deb-tace Hepatocellular carcinoma (HCC) TACE TIPS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiiated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.