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New combo therapy aims to shrink untreatable liver tumors

NCT ID NCT06794073

Disease control Sponsor: Shanghai Zhongshan Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a powerful combination of treatments for people with advanced liver cancer that cannot be surgically removed. The approach uses heat-based ablation to destroy the main tumor, followed by targeted therapy (lenvatinib), immunotherapy (tislelizumab), and a procedure that blocks the tumor's blood supply (TACE). The goal is to see if this multi-pronged attack can shrink tumors and improve survival. The trial is small, with only 17 participants, and is being conducted at a single center in China.

What this could mean

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

Active substance
Tislelizumab (PD-1 monoclonal antibody), lenvatinib, multimodal thermal ablation, and transarterial chemoembolization (TACE)
What this could lead to
If successful, this combination could shrink or control liver tumors that cannot be removed by surgery, potentially extending survival.
What could go wrong
This is a very small, early-phase trial with only 17 people and no comparison group. The combination may cause significant side effects, and results 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 17 people

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

Started

Jan 2026

Expected to finish

Aug 2027

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 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 18-80 years, regardless of gender. 2. Clinically or pathologically confirmed HCC. 3. CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation. 4. Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \>5 cm. 5. Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment.. 6. ECOG PS 0-1 and an expected survival \>3 months. 7. Child-Pugh score ≤7. Exclusion Criteria: 1. Child-Pugh class C liver dysfunction. 2. Tumor thrombus in the main portal vein or hepatic vein. 3. Extensive metastatic disease with an expected survival \<3 months. 4. Severe dysfunction of major organs (liver, kidney, heart, lung, or brain). 5. History of esophageal/gastric variceal bleeding within the past month. 6. History of other malignancies. 7. Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \<1 month. 8. Active infection; HBV co-infection (HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation. 9. History of organ transplantation or hepatic encephalopathy. 10. Uncorrectable coagulation disorders. 11. Refractory massive ascites, pleural effusion, or cachexia. 12. Pregnancy, impaired consciousness, or inability to comply with treatment. 13. High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \>12). 14. Any other condition deemed unsuitable by investigators that may affect study participation.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma digestive system neoplasm Digestive System Neoplasms epithelial neoplasm hepatocellular carcinoma liver and intrahepatic bile duct neoplasm Liver Neoplasms

As listed by the trial registrant

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

Adenocarcinoma Carcinoma, hepatocellular Digestive system neoplasms Liver neoplasms Neoplasms, glandular and epithelial

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.

    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

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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