ClinicalTrials.gg
Not yet recruitingNCT07912853IMPACTUpdated Nov 3, 2026

Integration of Imaging, Molecular, Pathological, and Clinical Outcome Data in Hepatocellular Carcinoma.

An observational study in Resectable Hepatocellular Carcinoma (HCC), sponsored by West China Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by West China Hospital · Observational

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
01

Study summary

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death globally. Surgical resection is the mainstay of curative-intent treatment, but the 5-year postoperative recurrence rate can be as high as 70%. Tumor heterogeneity is a major driver of recurrence and continues to complicate individualized treatment decision-making. For example, extended resection may improve radicality but risks hepatic decompensation, whereas limited resection preserves liver function but may leave microscopic invasive foci. Therefore, accurate preoperative evaluation of tumor invasiveness is critical to achieving a delicate balance between radicality and safety, and to improving long-term survival.

Multiparametric MRI is the most comprehensive noninvasive modality for assessing HCC invasiveness. However, most existing models are primarily data-driven and lack histopathological or molecular validation of their underlying mechanisms. They also lack precise spatial localization, limiting their direct application to surgical planning. A bottleneck is the lack of precise imaging-pathology correspondence, resulting from mismatches between macroscopic imaging and microscopic histology in both spatial registration and sampling adequacy. This gap also makes it difficult to establish a coherent link between imaging phenotypes and postoperative recurrence risk.

Therefore, this prospective observational cohort study aims to construct a multidimensional Imaging, Molecular, Pathological, And Clinical Outcome (IMPACT) database in patients undergoing curative resection for single BCLC 0/A HCC. The study has three major objectives:

  1. Cross-scale imaging-pathology-molecular correlations: to spatially correlate multiparametric MRI and photon-counting CT (PCCT) imaging features with pathologic and molecular features, as well as with prognosis, thereby elucidating the biological mechanisms underlying imaging markers and phenotypes.
  2. Prospective validation of prognostic models: to validate the predictive performance of the MERP, SPAN, and related models for recurrence-free survival (RFS), overall survival (OS), and other endpoints;
  3. Imaging-guided individualized surveillance: to explore the role of abbreviated MRI (AMRI)-based surveillance in the postoperative follow-up of patients at high risk of recurrence.

By integrating imaging phenotypes, pathological immune microenvironment, genomic alterations, and clinical outcomes into a four-dimensional radiogenomic framework, this database will support a shift towards the "imaging-as-virtual-biopsy" paradigm, inform individualized surgical planning, perioperative treatment, and postoperative surveillance.

02

Conditions studied

  • Resectable Hepatocellular Carcinoma (HCC)
03

In context

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

This study's planned enrollment of 380 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This prospective observational cohort will enroll adult patients with preserved liver function who undergo curative-intent resection for single BCLC 0/A HCCs.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to understand the study requirements, provide written , and comply with radiological examinations, biospecimen collection, and follow-up schedules.
  2. Age ≥18 years at the time of signing Informed Consent Form.
  3. Newly diagnosed HCC either clinically in accordance with the version 2026 Liver Imaging Reporting and Data System (LI-RADS) or pathologically via core-needle .
  4. Single BCLC 0/A HCC.
  5. HCC that is amenable to R0 surgical resection with curative intent in the opinion of the multidisciplinary tumor board involved in the care of the participant.
  6. No prior antitumor therapy.
  7. (ECOG) performance status of 0 or 1.
  8. class A liver function.
  9. No to contrast-enhanced CT or MRI, such as contrast-media allergy, claustrophobia, or incompatible metallic implants.
  10. No evidence of portal hypertension (CSPH) or minor CSPH (HVPG \<12 mmHg) in candidates for minor resection (fewer than 3 segments). Clinically significant portal hypertension (CSPH) can be defined either by its gold standard measurement, a hepatic venous pressure gradient (HVPG) ≥10 mmHg, or by the presence of surrogate markers such as a count \<100 × 109/L combined with splenomegaly.
  11. Adequate major organ function, with laboratory values obtained within 7 days before enrollment meeting the following criteria:

    Hematology: ≥ 1.0 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, ≥ 90 g/L ((no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], and no medication correction within 2 weeks prior to screening, except for hemoglobin).

    Blood chemistry: total ≤1.5 × (ULN); (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; albumin ≥ 30 g/L (no albumin or branched-chain amino acid supplementation within 14 days prior to screening); serum creatinine (Cr) ≤1.5 × ULN or Cr clearance > 50 mL/min ( formula); and urine protein ≤1+ ((if urine protein is ≥2+, 24-hour urine protein quantification can be performed, and patients with 24-hour urine protein quantification \< 1.0 g can be enrolled).

    Coagulation: (PT) exceeding the normal range ≤2 s; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.

  12. Documented virology status of hepatitis, as confirmed by screening tests for virus (HBV) and/or virus (HCV):

    Patients with hepatitis B virus (HBV) infection, such as HBsAg positive, should be tested for HBV-DNA, and HBV-DNA must be \< 2000 IU/mL (\< 104 copies/mL if the site has only copy/mL testing unit); for patients with HBV-DNA ≥ 2000 IU/mL, if they have received antiviral therapy (only nucleosides such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide fumarate tablets are allowed) for at least 1 week ,and the viral copy number is decreased more than 10-fold (1 lg) compared with that before treatment, they also can be enrolled. For patients with HBV infection, antiviral therapy is required throughout the study.

    Patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidenced by detectable HCV RNA), are eligible.

    For patients with detectable HCV RNA and for whom HCV treatment is considered appropriate by the investigator, treatment should begin no sooner than 6 months following liver resection consistent with AASLD guidelines.

  13. Negative test at screening with the following exception: Individuals with a positive HIV test at screening are eligible if they are stable on anti-retroviral therapy, have a ≥ 200/cells/µL, and have an undetectable viral load.
  14. For women of : agreement to remain abstinent (refrain from heterosexual intercourse) or use .

For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.

Exclusion criteria

Exclusion Criteria:

  1. Inadequate image quality for reliable analyses (e.g., severe artifact, incomplete images).
  2. Imaging evidence of tumor rupture at baseline.
  3. History of hepatic encephalopathy if within one year prior to screening.
  4. Clinically symptomatic moderate-to-severe ascites.
  5. History of prior .
  6. Active co-infection with and (defined as detectable HCV RNA plus positive HBV surface antigen or HBV DNA). Patients with a history of HCV infection but who are negative for HCV RNA by Polymerase Chain Reaction (PCR) will be considered non-infected with HCV.
  7. Known active co-infection with HBV and hepatitis D viral infection (HDV).
  8. Active bleeding or bleeding diathesis, or those receiving ongoing thrombolytic, anticoagulant, or antiplatelet therapy.
  9. High-grade esophageal or gastric fundal varices requiring intervention.
  10. Inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mmHg and/or diastolic BP > 100 mmHg (average of at least three readings at two or more sessions). Anti-hypertensive therapy to achieve these parameters is allowed.
  11. History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to screening.
  12. History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction, including subocclusive or occlusive syndrome related to the underlying disease, or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to screening.
  13. Evidence of abdominal free air that is not explained by paracentesis or recent (\< 3 months) abdominal surgical procedure.
  14. Serious, non-healing, or dehiscing wound, active ulcer, or untreated bone fracture.
  15. History of intra-abdominal inflammatory process within 6 months prior to screening, including but not limited to peptic ulcer disease, diverticulitis, or colitis.
  16. Major surgical procedure, open , or significant traumatic injury within 28 days prior to screening; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to screening; or anticipation of need for major surgical procedure, other than potentially curative liver resection, during the study; or non-recovery from side effects of any such procedure.
  17. Failuere to achieve complete healing from minor surgery (e.g., simple excision, tooth extraction) must have occurred at least 7 days before screening.
  18. Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID). The occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed.
  19. Serious infection requiring oral or IV antibiotics and/or hospitalization within 4 weeks prior to screening, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety.
  20. Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female participants of must have a negative serum pregnancy test result at screening.
  21. (LVEF) \< 50% assessed by either transthoracic echocardiogram (TTE) or multiple-gated acquisition (MUGA) scan (TTE preferred test) within 6 months prior to screening.
  22. Active tuberculosis.
  23. Ongoing psychotropic substance abuse that cannot be discontinued or with a clinically significant psychiatric disorder.
  24. Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study.
  25. Subjects considered ineligible at the investigator's discretion, with the rationale explicitly documented.
  26. Non R0 resection.
  27. Incomplete surgical records (e.g., missing data on whether anatomical resection was performed).
  28. Unable to complete scheduled postoperative surveillance.
Terms in these criteria, in plain language(22)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
380 participants (estimated)
Patient registry
No

Groups and cohorts

  • Curative Resection HCC Cohort

    Procedure: Resection

Interventions

  • ProcedureResection

    Hepatocellular carcinoma that is amenable to R0 surgical resection with curative intent in the opinion of the multidisciplinary tumor board involved in the care of the participant.

06

What researchers measure

Primary outcomes

  1. Recurrence-free Survival (RFS)

    Recurrence-free survival is defined as the time from resection of HCC to the first documented tumor recurrence or death from any cause, whichever occurs first. Participants without recurrence or death will be censored at the date of their last follow-up. Characteristics of recurrence, including but not limited to recurrence location, proximity to the surgical margin, tumor size, and number of recurrent lesions, will be collected at the time of recurrence.

    Time frame: From resection to the first documented recurrence or death from any cause, whichever occurs first, assessed up to 3 years.

Secondary outcomes

  1. Overall Survival (OS)

    Overall survival is defined as the time from resection of HCC to death from any cause. Participants who are alive at the last follow-up will be censored at the date of last contact. The cause of death will be adjudicated and classified as tumor-related or non-tumor-related.

    Time frame: From resection to death from any cause, assessed up to 3 years

  2. Time to recurrence (TTR)

    Time to recurrence is defined as the time from resection of HCC to the first documented tumor recurrence. Participants without recurrence will be censored at the date of their last follow-up. Characteristics of recurrence, including recurrence location, proximity to the surgical margin, tumor size, and number of recurrent lesions, will be collected at the time of recurrence.

    Time frame: From resection to the first documented recurrence, assessed up to 3 years.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912853
Responsible party
Hanyu Jiang (Associate Chief Physician, West China Hospital) — Principal investigator
First posted
Nov 3, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

Hanyu Jiang
Contact
hanyu_jiang@foxmail.com
+86 18608008770

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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