Hepotacellular CarcinomaPhase 1/2NCT07282184
Multimodal Deep Learning for Postoperative Liver Cancer Risk Stratification and Intervention
A Phase 1/2 study testing Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor, Curative Liver Resection and Multimodal AI Risk Stratification in people with Hepotacellular Carcinoma, run by Tongji Hospital at 1 site in China.
Trial summary
This study is for patients with early-stage liver cancer who are planning to have surgery. The goal of this research is to see if a personalized treatment plan, guided by a computer model (an artificial intelligence tool), can help prevent the cancer from coming back after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepotacellular Carcinoma
- What is being tested?
- Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor, Curative Liver Resection and Multimodal AI Risk Stratification
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2025to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 438700
Yang WU, M.D., +8613636076910, 255001907@qq.com
wgzhang@tjh.tjmu.edu.cn
About this study
Official title: A Multimodal Deep Learning-Driven Study for Perioperative Risk Stratification and Precision Intervention in Hepatocellular Carcinoma Recurrence
This study is for patients with early-stage liver cancer who are planning to have surgery. The goal of this research is to see if a personalized treatment plan, guided by a computer model (an artificial intelligence tool), can help prevent the cancer from coming back after surgery.
First, the computer model will analyze each patient's medical images and health data to predict their personal risk of the cancer returning. Patients whom the model predicts have a high risk of the cancer coming back will be offered a special treatment plan. This plan involves receiving medication (neoadjuvant therapy) before surgery and additional medication (adjuvant therapy) after surgery. The effectiveness of this plan will be compared to the standard approach of surgery alone.
Read more
The main goal is to see if this new, personalized plan can better prevent the cancer from returning within 2 years after surgery. The study will also closely monitor the safety of the medications used.
All patients in the study will be followed closely for 2 years with regular scans and check-ups to monitor their health.
- Conditions
- Hepotacellular Carcinoma
- Being tested
- Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor, Curative Liver Resection, Multimodal AI Risk Stratification
- Keywords
- deep learning, recurrence pattern, Hepatocellular Carcinoma, Neoadjuvant Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant HAIC + Lenvatinib + PD-1 InhibitorCombination product
A combination drug regimen used as neoadjuvant therapy. Includes Hepatic Arterial Infusion Chemotherapy (HAIC) with mFOLFOX6 (Oxaliplatin, Leucovorin, Fluorouracil), oral Lenvatinib, and an intravenous PD-1 inhibitor.
Curative Liver ResectionProcedure or surgery
Standard anatomic or non-anatomic liver resection with the intention of achieving complete tumor removal with negative margins. This is the standard surgical procedure for resectable hepatocellular carcinoma
Multimodal AI Risk StratificationOther
The use of a pre-established deep learning model (PRE/POST model) to analyze preoperative imaging and clinical data to stratify patients' risk of aggressive recurrence. This stratification is used to determine treatment arm assignment.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal AI-guided Neoadjuvant Therapy + Surgery | Experimental | Participants identified as high-risk for recurrence by the multimodal deep learning (PRE) model receive neoadjuvant therapy prior to curative liver resection. The neoadjuvant regimen consists of hepatic arterial infusion chemotherapy (HAIC) with the mFOLFOX6 regimen, combined with a PD-1 inhibitor and Lenvatinib. This is followed by standard curative liver resection. Receives: Combination Product: Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor; Procedure: Curative Liver Resection; Other: Multimodal AI Risk Stratification |
| Surgery Alone (High-Risk) | Active comparator | Participants identified as high-risk for recurrence by the multimodal deep learning (PRE) model proceed directly to standard curative liver resection without receiving neoadjuvant therapy. Receives: Procedure: Curative Liver Resection; Other: Multimodal AI Risk Stratification |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Recurrence-free Survival (RFS) Rate
The primary outcome is the proportion of patients who remain free of recurrence at 2 years after curative liver resection. Recurrence is defined as radiologically confirmed (via contrast-enhanced CT or MRI according to RECIST 1.1 criteria) appearance of new lesions (intrahepatic or extrahepatic) or death from any cause, whichever occurs first. This outcome will be compared between the intervention arm (AI-guided neoadjuvant therapy + surgery) and the control arm (surgery alone).
Measured: 2 years post-surgery
Secondary outcomes (2)
Incidence of Grade 3 or Higher Treatment-Related Adverse Events (TRAEs)
The proportion of patients in the intervention arm who experience at least one Grade 3 or higher adverse event that is judged by the investigator to be related to the neoadjuvant therapy regimen (HAIC + Lenvatinib + PD-1 inhibitor). Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From the start of neoadjuvant therapy until 30 days after the last dose of neoadjuvant drugs
Overall Survival (OS)
The time from the date of randomization (or enrollment for non-randomized studies) to the date of death from any cause. Patients who are still alive at the time of analysis will be censored at the last known date they were alive.
Measured: Up to 3 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start26 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepotacellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Guang Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282184
- Sponsor's protocol ID
- TJ-IRB202510021
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Deep Learning-Driven Study for Perioperative Risk Stratification and Precision Intervention in Hepatocellular Carcinoma Recurrence
- ClinicalTrials.gov ID
- NCT07282184
- Acronym / sponsor ID
- TJ-IRB202510021
- Conditions
- Hepotacellular Carcinoma
- Keywords
- deep learning, recurrence pattern, Hepatocellular Carcinoma, Neoadjuvant Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 26 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients with early-stage liver cancer who are planning to have surgery. The goal of this research is to see if a personalized treatment plan, guided by a computer model (an artificial intelligence tool), can help prevent the cancer from coming back after surgery.
First, the computer model will analyze each patient's medical images and health data to predict their personal risk of the cancer returning. Patients whom the model predicts have a high risk of the cancer coming back will be offered a special treatment plan. This plan involves receiving medication (neoadjuvant therapy) before surgery and additional medication (adjuvant therapy) after surgery. The effectiveness of this plan will be compared to the standard approach of surgery alone.
The main goal is to see if this new, personalized plan can better prevent the cancer from returning within 2 years after surgery. The study will also closely monitor the safety of the medications used.
All patients in the study will be followed closely for 2 years with regular scans and check-ups to monitor their health.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal AI-guided Neoadjuvant Therapy + Surgery | Experimental | Combination Product: Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor, Procedure: Curative Liver Resection, Other: Multimodal AI Risk StratificationParticipants identified as high-risk for recurrence by the multimodal deep learning (PRE) model receive neoadjuvant therapy prior to curative liver resection. The neoadjuvant regimen consists of hepatic arterial infusion chemotherapy (HAIC) with the mFOLFOX6 regimen, combined with a PD-1 inhibitor and Lenvatinib. This is followed by standard curative liver resection. |
| Surgery Alone (High-Risk) | Active comparator | Procedure: Curative Liver Resection, Other: Multimodal AI Risk StratificationParticipants identified as high-risk for recurrence by the multimodal deep learning (PRE) model proceed directly to standard curative liver resection without receiving neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant HAIC + Lenvatinib + PD-1 InhibitorA combination drug regimen used as neoadjuvant therapy. Includes Hepatic Arterial Infusion Chemotherapy (HAIC) with mFOLFOX6 (Oxaliplatin, Leucovorin, Fluorouracil), oral Lenvatinib, and an intravenous PD-1 inhibitor. | Combination product | Multimodal AI-guided Neoadjuvant Therapy + Surgery |
| Curative Liver ResectionStandard anatomic or non-anatomic liver resection with the intention of achieving complete tumor removal with negative margins. This is the standard surgical procedure for resectable hepatocellular carcinoma | Procedure or surgery | Multimodal AI-guided Neoadjuvant Therapy + Surgery, Surgery Alone (High-Risk) |
| Multimodal AI Risk StratificationThe use of a pre-established deep learning model (PRE/POST model) to analyze preoperative imaging and clinical data to stratify patients' risk of aggressive recurrence. This stratification is used to determine treatment arm assignment. | Other | Multimodal AI-guided Neoadjuvant Therapy + Surgery, Surgery Alone (High-Risk) |
Primary outcome
2-year Recurrence-free Survival (RFS) Rate
Time frame: 2 years post-surgery
The primary outcome is the proportion of patients who remain free of recurrence at 2 years after curative liver resection. Recurrence is defined as radiologically confirmed (via contrast-enhanced CT or MRI according to RECIST 1.1 criteria) appearance of new lesions (intrahepatic or extrahepatic) or death from any cause, whichever occurs first. This outcome will be compared between the intervention arm (AI-guided neoadjuvant therapy + surgery) and the control arm (surgery alone).
2 secondary outcomes
Incidence of Grade 3 or Higher Treatment-Related Adverse Events (TRAEs)
Time frame: From the start of neoadjuvant therapy until 30 days after the last dose of neoadjuvant drugs
Overall Survival (OS)
Time frame: Up to 3 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor, Curative Liver Resection and Multimodal AI Risk Stratification in people with Hepotacellular Carcinoma, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Wu, M.D. (+8613636076910, 255001907@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Recurrence-free Survival (RFS) Rate (time frame: 2 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.