Liver cancer remission: is surgery still needed?
NCT ID NCT05349331
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at liver cancer patients whose tumors shrank completely after non-surgical treatments like chemoembolization and immunotherapy. Researchers compared those who then had surgery to remove any remaining tissue versus those who simply watched and waited. The goal was to see which approach leads to better survival and fewer recurrences. 74 patients took part in this phase 2 trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Liver resection surgery
- What this could lead to
- If successful, this could show that some liver cancer patients can safely avoid surgery after a complete response to initial therapy, reducing treatment burden.
- What could go wrong
- This is a small, phase 2 trial with only 74 participants, so results may not apply broadly. The watch-and-wait approach carries a risk of hidden tumor cells causing recurrence.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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74 people
The number who actually took part.
- Started
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May 2022
- Finished
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Jan 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age ≥18 years old. * Patients with clinical diagnosis of hepatocellular carcinoma without extrahepatic metastasis, and two liver surgeons evaluated as unresectable. * AFP≥400ug/L or PIVKA-II≥1000mAU/mL before initial treatment. * Initial treatment is hepatic arterial intervention (chemoembolization/infusion chemotherapy), combined targeted therapy (sorafenib, lenvatinib, donafenib, apatinib, bevacizumab) and immune checkpoint inhibitor therapy (PD-1\\PD-L1). * After transarterial infusion chemotherapy combined with targeted and immunotherapy treatment, the tumor evaluation is clinical complete response, that is, the following two criteria are met: 1. Two consecutive imaging assessments (one month apart) tumor complete response (CR, mRECIST) standard) 2. Two consecutive tumor markers (one month apart) AFP and PIVKA-II ≤ the upper limit of the normal value * The patients with clinical complete response were evaluated by two liver surgeons as resectable. * Normal hematological function (platelets\>75×109/L; leukocytes\>3.0×109/L; neutrophils\>1.5×109/L) * Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 3 times ULN * No ascites, normal coagulation function, albumin≥30g/L * Child-Pugh class A * Serum creatinine less than 1.5 times the upper limit of normal (ULN) * ECOG score 0-1 * Life expectancy \> 3 months Exclusion Criteria: * Received other tumor treatments other than hepatic artery interventional therapy, targeted and immunotherapy * Any of the following conditions within the first 12 months of the study: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), Pulmonary embolism; ongoing: arrhythmia of grade ≥2 by NCI-CTCAE criteria, QTc prolongation (\>450 ms in men, \>470 ms in women); * Renal insufficiency requires peritoneal dialysis or hemodialysis; * Serious dysfunction of other important organs; * A second primary malignant tumor was diagnosed in the past; * Known or new evidence of brain or leptomeningeal lesions; Hemophilia or bleeding tendency, taking anticoagulation therapy such as coumarin derivatives in therapeutic doses; * Pregnant or lactating women, all female patients of childbearing potential must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative; * History of previous organ transplantation; * Known HIV infection; * Allergy to chemotherapy drugs; * Patients with other serious acute or chronic physical or psychiatric diseases or abnormal laboratory tests that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results or the investigators consider unsuitable for enrollment.
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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.
Contacts and locations
Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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