AI predicts liver cancer return, guides personalized drug cocktail
NCT ID NCT07282184
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for people with early-stage liver cancer who are scheduled for surgery. Researchers are testing whether an artificial intelligence (AI) tool can predict each patient's risk of the cancer returning. Patients identified as high-risk will receive a combination of chemotherapy, targeted therapy, and immunotherapy before and after surgery. The goal is to see if this personalized plan improves the chance of staying cancer-free for two years compared to surgery alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combination of chemotherapy (HAIC with mFOLFOX6), oral Lenvatinib, and a PD-1 inhibitor
- What this could lead to
- If successful, this approach could offer a personalized treatment plan that significantly lowers the chance of liver cancer returning after surgery.
- What could go wrong
- This is an early-phase trial with only 144 participants, so results may not apply to everyone. The drug combination can cause serious side effects, and the AI tool's predictions may not always be accurate.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- 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 to 75 years
- 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 and Consent: Patients aged 18-75 years who are able to understand and voluntarily sign an Informed Consent Form. * Diagnosis: Clinical diagnosis of BCLC stage 0-A hepatocellular carcinoma, confirmed by histopathology or non-invasive imaging criteria per guidelines. * Surgical Candidacy: Scheduled to undergo curative-intent liver resection. * Risk Stratification: Predicted as high-risk for aggressive recurrence by the pre-operative multimodal deep learning model (PRE score ≥ 0.5). * Liver Function: Child-Pugh liver function class A (score ≤ 7). * Performance Status: ECOG Performance Status of 0 or 1. * Imaging Requirement: Availability of a standard pre-operative MRI scan (including non-contrast, arterial, portal venous, and delayed phases) performed within 1 month prior to enrollment, with acceptable image quality. * Follow-up Commitment: Willing and able to comply with the study procedures and scheduled follow-up for at least 2 years. Exclusion Criteria: * Pathology: Postoperative pathological confirmation of non-HCC malignancy (e.g., cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma). * Other Malignancies: History of other active malignancies within the past 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or other cancers with a very low risk of recurrence. * Early Mortality/Loss: Death from any cause or loss to follow-up within 90 days after surgery. * Contraindications to Protocol Therapy: Known hypersensitivity to any component of the neoadjuvant therapy regimen (e.g., oxaliplatin, fluorouracil, PD-1 inhibitors, lenvatinib). * Severe, uncontrolled medical conditions including but not limited to: Uncontrolled cardiac disease (e.g., NYHA Class III or IV heart failure), Severe renal dysfunction, Uncontrolled hypertension. * Inability to Participate: Any condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study or interfere with the evaluation of the study objectives.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tongji Hospital
RECRUITINGWuhan, Hubei, 438700, China
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