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Can adding a fourth drug shrink large liver tumors that invade the portal vein?

NCT ID NCT06904183

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing whether adding hepatic arterial infusion chemotherapy (HAIC) to a combination of lenvatinib, sintilimab, and drug-eluting bead chemoembolization (DEB-TACE) can better control large liver cancers (over 7 cm) that have spread into the portal vein. About 320 participants will be randomly assigned to receive either the three-part or four-part treatment. The main goal is to see how long it takes for the cancer to progress, with secondary goals including response rates and overall survival.

What this could mean

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

Active substance
A combination of lenvatinib (a targeted therapy), sintilimab (an immunotherapy), drug-eluting bead transarterial chemoembolization (DEB-TACE), and hepatic arterial infusion chemotherapy (HAIC) with FOLFOX regimen.
What this could lead to
If adding HAIC improves outcomes, it could offer a more effective treatment option for people with large liver cancers that have spread into the portal vein.
What could go wrong
This is a phase 2 trial, so results are preliminary. The added chemotherapy may increase side effects without improving overall survival, and the benefit may not apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 320 people

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

Started

Apr 2025

Expected to finish

Mar 2030

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: * a confirmed diagnosis of HCC * the largest intrahepatic lesion \>7 cm * presence of PVTT on imaging * tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment * Eastern Cooperative Oncology Group performance status ≤1 * Child-Pugh class A/B * adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds * life expectancy of at least 3 months Exclusion Criteria: * accompanied with vena cava tumor thrombus * central nervous system involvement * previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy * organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment * history of other malignancies * uncontrollable infection * history of HIV * history of organ or cells transplantation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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.

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  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 Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510260, China

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