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Immunotherapy plus radiation aims to stop liver cancer recurrence

NCT ID NCT07186621

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tests whether combining radiotherapy with the immunotherapy drug sintilimab can better prevent liver cancer from coming back after surgery, compared to the standard TACE procedure. The study enrolls 286 adults with high-risk features like narrow surgical margins or microvascular invasion. Participants will receive either the combination therapy or TACE, and researchers will track cancer recurrence and survival over two years.

What this could mean

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

Active substance
Sintilimab (an immunotherapy drug) and radiotherapy (targeted radiation)
What this could lead to
If successful, this combination could offer a more effective way to prevent liver cancer from coming back after surgery, potentially improving survival without the need for repeated procedures.
What could go wrong
This is a mid-stage trial, so results are not guaranteed. The experimental treatment may cause side effects like immune-related inflammation or radiation damage, and it may not prove better than the standard TACE approach.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 286 people

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

Started

Jul 2025

Expected to finish

Nov 2028

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. R0 resection of hepatocellular carcinoma (HCC) with a surgical margin \<1 cm (determined by postoperative pathology, surgical records, and imaging). 2. Within 4 months after curative resection. 3. High-Risk Recurrence Factors (at least one required in addition to narrow margin): (1) Microvascular invasion (MVI) positive, tumor thrombus, or satellite nodules (2) Preoperative AFP \>400 ng/mL (3) Tumor \>5 cm with incomplete capsule 4. ≥18 and ≤80 years old. 5. ECOG score 0-1. 6. Child-Pugh Class: A5, A6, or B7. 7. Postoperative Contrast-enhanced MRI of the liver must be performed to exclude intrahepatic residual lesions. 8. HBV DNA and HCV RNA status do not affect eligibility, but if HBV DNA positive and/or HCV RNA positive: ALT must be \<1.5× upper limit of normal (ULN). Antiviral therapy must be initiated. 9. Liver Function Tests (LFTs): ALT ≤2.5× ULN (if HBV/HCV positive, ALT ≤1.5× ULN). If ALT ≤1.5× ULN, AST ≤6× ULN (excluding AST elevation due to myocardial infarction). If ALT 1.5-2.5× ULN, AST ≤2.5× ULN. 10. No significant ECG abnormalities and no severe cardiac dysfunction. 11. Serum creatinine (CRE) and BUN ≤2.5× ULN. 12. Hb≥80g/L,ANC≥1.0×109 /L,PLT≥40×109 /L. 13. Written informed consent obtained. Exclusion Criteria: 1. Vp3 or Vp4 portal vein tumor thrombus (PVTT) or Vv2/Vv3 inferior vena cava (IVC) tumor thrombus on preoperative imaging. 2. Previous anti-HCC therapies, including but not limited to: targeted therapy (e.g., tyrosine kinase inhibitors), immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) or systemic chemotherapy 3. Distant metastasis before randomization. 4. Moderate to severe ascites unresponsive to medical management. 5. History of other malignancies, except: carcinoma in situ,early-stage papillary thyroid cancer or basal cell carcinoma of the skin 6. Previous radiotherapy involving the abdomen. 7. Significant cardiac, renal, or other major organ dysfunction. 8. Active Autoimmune Disease or Psychiatric Disorders. 9. HIV Infection. 10. Pregnant or breastfeeding women. 11. Currently enrolled in another interventional clinical trial.

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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.

  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

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

More trials for these conditions

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