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Should liver cancer patients get surgery after drugs work? new study aims to find out

NCT ID NCT07290764

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at people with liver cancer that was too large or spread out to remove with surgery, but then completely disappeared after drug treatment. Researchers want to see if having surgery after the drugs work helps people live longer compared to just watching and waiting. About 729 patients will be followed for three years to compare survival rates.

What this could mean

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

Active substance
surgical resection
What this could lead to
If successful, this could show that surgery after complete remission improves long-term survival for patients with initially unresectable liver cancer.
What could go wrong
This is an observational study, not a randomized trial, so results may be biased. The findings may not apply to all patients, and surgery carries its own risks.

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 729 people

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

Started

Dec 2025

Expected to finish

Jun 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, the tumor response reached complete remission after systematic treatment.

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. Aged between 18 and 75 2. Child-Pugh: A/B grade 3. ECOG score: ≤1 point 4. The clinical or pathological diagnosis is consistent with primary HCC, and it has been evaluated by two senior hepatobiliary surgeons as surgically unresectable (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis). 5. According to the mRECIST criteria, the patient has at least one measurable lesion (the long diameter of the measurable lesion on CT/MRI scans is ≥10mm, and the measurable lesion has not previously received local treatments such as interventional therapy, radiotherapy, or cryotherapy) 6. Patients who achieved CR in tumor response after conversion therapy (based on systemic therapy) (rCR definition: The lesion is completely necrotic as evaluated by enhanced CT/MRI according to the mRECIST criteria;cCR is defined as: reaching rCR according to mRECIST criteria, having no distant metastatic lesions, normal AFP and DCP indicators, and maintaining the above criteria for ≥4weeks); Moreover, it can be surgically removed, with no contraindications for surgery or anesthesia 7. The expected survival time is more than three months 8. The functional indicators of important organs should meet the following requirements: · Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L, Hb ≥ 9.0 g/L, PLT ≥ 75 × 109/L; · Liver function: Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN) (for those with obstructive jaundice, after biliary drainage, it should be ≤ 2.5 times ULN); Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤ 5 times ULN, Albumin ≥ 30 g/L; · Kidney function: Serum creatinine ≤ 1.5 mg/dL, Creatinine clearance rate ≥ 60 ml/min; · Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. 9. No history of severe arrhythmia, heart failure, etc. There is no history of severe ventilation dysfunction or serious pulmonary infection 10. Fertile women should agree to use contraceptive measures during the medication period and for 6 months after the medication is stopped; within 7 days before the study enrollment, the serum or urine pregnancy test must be negative, and the patient must be non-lactating. For male patients, they should agree to use contraceptive measures during the study period and for 6 months after the study is over Exclusion Criteria: 1. Those who have had other malignant tumor histories within the past 5 years or simultaneously, but have been cured, such as skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma, are excluded 2. Patients who have received organ transplants in the past or are planning to receive organ transplants 3. Patients with any active autoimmune diseases or those with autoimmune diseases and expected recurrence (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes) 4. Have a history of immune deficiency; Patients who are currently undergoing immunosuppressant or systemic hormone therapy to achieve immunosuppressive effects and are still using them within two weeks prior to signing the informed consent form 5. Known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombosis tendencies, such as in patients with hemophilia; currently using or having used full-dose oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes (allowing for the preventive use of low-dose aspirin or low-molecular-weight heparin within 10 days prior to the start of the study treatment) 6. Within 4 weeks prior to the first use of the investigational drug, there was a severe infection, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; the baseline chest imaging examination indicated active pulmonary inflammation; within 2 weeks prior to the first use of the investigational drug, there were symptoms and signs of infection or the need for oral or intravenous antibiotic treatment (excluding the use of antibiotics for prophylaxis) 7. Patients with concurrent mental disorders; Has a history of abuse of psychotropic drugs, alcoholism and drug abuse 8. Pregnant or lactating women 9. Those who, as determined by the researchers, are not suitable to participate in this trial for other reasons

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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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian, China

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