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Immune cell boost plus targeted procedure shows promise for inoperable liver tumors

NCT ID NCT07209813

Disease control Sponsor: Beijing Gene Key Life Technology Co., Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether adding a special immune cell infusion (GKL-006) to a standard procedure that blocks blood flow to tumors (TACE) can shrink liver cancers that cannot be removed by surgery. About 48 adults with unresectable hepatocellular carcinoma will receive the combination or TACE alone. The main goal is to see how many patients' tumors shrink significantly.

What this could mean

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

Active substance
GKL-006 (a type of immune cell called iNKT cells) given as an infusion, combined with TACE (a procedure that blocks blood flow to the tumor)
What this could lead to
If successful, this combination could offer a new way to shrink or control liver tumors that cannot be surgically removed, potentially extending life or making transplant possible.
What could go wrong
This is an early Phase 2 trial with only 48 people, so results may not apply to everyone. The treatment may cause side effects or fail to improve outcomes compared to TACE 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.

Phase

Phase 2

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

Participants

About 48 people

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

Started

Nov 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

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.

Main Inclusion Criteria: * Voluntarily participates in the study and provides written informed consent. * Male or female, age ≥ 18 and ≤ 80 years old * Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma. * Has CNLC stage II to IIIa disease. * Has at least one measurable lesion according to mRECIST. * Child-Pugh class A or B. * ECOG performance status of 0 - 2. * Adequate hematologic and organ function. Main Exclusion Criteria: * Has a known allergy to the investigational product or related components, including human serum albumin and IL-2. * Has another incurable malignancy within 5 years before screening or concurrently. * Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma. * Has received therapy aim to target lesion(s) within 12 weeks before screening. * Has hepatic encephalopathy within 4 weeks before screening. * Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage. * Has other active disease.

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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.

Hepatocellular carcinoma Hepatocellular carcinoma (HCC) Unresectable hepatocellular cancer

How to take part

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

  1. The places running it

    7 sites. 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

  • 302 Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100039, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Nanjing Second Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

  • Zhongda Hospital

    RECRUITING

    Nanjing, Jiangsu, 210009, China

More trials for these conditions

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