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Triple therapy boosts survival in tough liver cancer cases

NCT ID NCT06631326

Disease control Sponsor: First Hospital of China Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a liver-directed chemotherapy infusion (HAIC) to the usual combination of lenvatinib and an immunotherapy drug (PD-1 inhibitor) helps people with advanced liver cancer that has spread into the main blood vessel of the liver. 244 patients with high tumor burden and portal vein tumor thrombus were included. The triple therapy improved overall survival and delayed cancer growth compared to the two-drug regimen alone.

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.

Participants

244 people

The number who actually took part.

Started

Jan 2021

Finished

Oct 2025

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.

Who is studied

Patients with high tumor burden advanced HCC with PVTT who received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.

Ages

18 to 80 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. Age 18 to 80 years old; 2. Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline; 3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria; 4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa. 5. Presence of PVTT; 6. Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib. 7. Child-Pugh class A or B7; 8. Tumor burden meets up to 7 out criteria. Exclusion Criteria: 1. Patients who took anti-tumor treatments before the combination therapy; 2. With other malignant tumors; 3. incomplete data.

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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.

BCLC stage C hepatocellular carcinoma HCC - hepatocellular carcinoma Hepatic arterial infusion chemotherapy Lenvatinib PD-1 inhibitors

Contacts and locations

Locations

  • The first hospital of China medical university

    Shenyang, Liaoning, 110000, China

More trials for these conditions

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