Can adding a fourth drug shrink large liver tumors that invade the portal vein?
NCT ID NCT06904183
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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The Second Affiliated Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, 510260, China
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Other studies related to the condition(s) this trial covers.
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- New combo therapy aims to stop liver cancer in its tracks
- New combo therapy aims to shrink liver tumors in Hard-to-Treat patients