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Can scans tell who needs surgery after liver tumor shrinks?

NCT ID NCT07581769

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks back at 500 people with liver cancer that could not be removed at first. After a mix of treatments (TACE, lenvatinib, and an immunotherapy drug), their tumors shrank enough to consider surgery. Researchers want to see if using scans and patient data can help decide who should have surgery and who should keep taking medicine for better long-term results.

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

About 500 people

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

Started

Jan 2018

Expected to finish

Dec 2026

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.

Who is studied

Patients with initially unresectable hepatocellular carcinoma who were treated with a combination therapy of TACE, lenvatinib, and a PD-1 inhibitor and subsequently achieved successful tumor downstaging.

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. Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria; 2. Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation; Underwent treatment with TACE combined with lenvatinib and a PD-1 inhibitor, after which the tumor was re-evaluated and deemed resectable by surgical assessment; 3. Following the achievement of surgical resectability criteria, patients subsequently underwent either R0 surgical resection or continued treatment with TACE combined with lenvatinib and a PD-1 inhibitor; 4. Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment; 5. Performance status (PS) score of 0 or 1. Exclusion Criteria: 1. Patients with unclear diagnoses or those with concurrent other malignancies. 2. For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively. 3. For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors. 4. Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy. 5. Patients with severe infections, such as respiratory, biliary tract, or abdominal infections. 6. Patients with severe underlying diseases, particularly immune-related disorders.

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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.

Downstaging Hepatocellular carcinoma (HCC) Lenvatinib Liver resection PD1 antibody Transarterial chemoembolization

Contacts and locations

Locations

  • The First Affiiated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280, China

More trials for these conditions

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