Resectable Hepatocellular Carcinoma (HCC)IMPACTNCT07912853
Integration of Imaging, Molecular, Pathological, and Clinical Outcome Data in Hepatocellular Carcinoma.
An observational study of Resectable Hepatocellular Carcinoma (HCC), run by West China Hospital at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Hepatocellular Carcinoma (HCC)
- What is being tested?
- Resection
- Type of treatment
- Surgery or procedure
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Able to understand the study requirements, provide written informed consent, and comply with radiological examinations, biospecimen collection, and follow-up schedules.
- Age ≥18 years at the time of signing Informed Consent Form.
- Newly diagnosed HCC either clinically in accordance with the version 2026 Liver Imaging Reporting and Data System (LI-RADS) or pathologically via core-needle biopsy.
- Single BCLC 0/A HCC.
- 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.
- No prior antitumor therapy.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Child-Pugh class A liver function.
- No contraindications to contrast-enhanced CT or MRI, such as contrast-media allergy, claustrophobia, or incompatible metallic implants.
- No evidence of clinically significant 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 platelet count <100 × 109/L combined with splenomegaly.
- Adequate major organ function, with laboratory values obtained within 7 days before enrollment meeting the following criteria:
- Hematology: absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 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 bilirubin ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (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 (Cockcroft-Gault 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: prothrombin time (PT) exceeding the normal range ≤2 s; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus (HBV) and/or hepatitis C 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.
- Negative HIV 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 CD4 count ≥ 200/cells/µL, and have an undetectable viral load.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.
Who cannot join
- Inadequate image quality for reliable analyses (e.g., severe artifact, incomplete images).
- Imaging evidence of tumor rupture at baseline.
- History of hepatic encephalopathy if clinically significant within one year prior to screening.
- Clinically symptomatic moderate-to-severe ascites.
- History of prior malignancy.
- Active co-infection with HBV and HCV (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.
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- Known active co-infection with HBV and hepatitis D viral infection (HDV).
- Active bleeding or bleeding diathesis, or those receiving ongoing thrombolytic, anticoagulant, or antiplatelet therapy.
- High-grade esophageal or gastric fundal varices requiring intervention.
- 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.
- History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to screening.
- 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.
- Evidence of abdominal free air that is not explained by paracentesis or recent (< 3 months) abdominal surgical procedure.
- Serious, non-healing, or dehiscing wound, active ulcer, or untreated bone fracture.
- History of intra-abdominal inflammatory process within 6 months prior to screening, including but not limited to peptic ulcer disease, diverticulitis, or colitis.
- Major surgical procedure, open biopsy, 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.
- Failuere to achieve complete healing from minor surgery (e.g., simple excision, tooth extraction) must have occurred at least 7 days before screening.
- 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.
- 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.
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female participants of childbearing potential must have a negative serum pregnancy test result at screening.
- Left ventricular ejection fraction (LVEF) < 50% assessed by either transthoracic echocardiogram (TTE) or multiple-gated acquisition (MUGA) scan (TTE preferred test) within 6 months prior to screening.
- Active tuberculosis.
- Ongoing psychotropic substance abuse that cannot be discontinued or with a clinically significant psychiatric disorder.
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study.
- Subjects considered ineligible at the investigator's discretion, with the rationale explicitly documented.
- Non R0 resection.
- Incomplete surgical records (e.g., missing data on whether anatomical resection was performed).
- Unable to complete scheduled postoperative surveillance.
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
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Hanyu Jiang, +86 18608008770, hanyu_jiang@foxmail.com
About this study
Official title: Integration of Multidimensional Imaging, Molecular, Pathological, And Clinical Outcome Data in Hepatocellular Carcinoma: Collection of the Prospective IMPACT Cohort.
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.
Read more
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:
- 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.
- 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;
- 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.
- Being tested
- Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Curative Resection HCC Cohort | Not described Receives: Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From resection to the first documented recurrence or death from any cause, whichever occurs first, assessed up to 3 years.
Secondary outcomes (2)
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.
Measured: From resection to death from any cause, assessed up to 3 years
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.
Measured: From resection to the first documented recurrence, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by West China 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanyu Jiang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912853
- Sponsor's protocol ID
- HX (2433)
- Other IDs
- 82622057
- Acronym
- IMPACT
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Multidimensional Imaging, Molecular, Pathological, And Clinical Outcome Data in Hepatocellular Carcinoma: Collection of the Prospective IMPACT Cohort.
- ClinicalTrials.gov ID
- NCT07912853
- Acronym / sponsor ID
- IMPACT / HX (2433)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Nov 2026 (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.
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:
- 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.
- 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;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curative Resection HCC Cohort | – | Procedure: Resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (21 listed)
- Able to understand the study requirements, provide written informed consent, and comply with radiological examinations, biospecimen collection, and follow-up schedules.
- Age ≥18 years at the time of signing Informed Consent Form.
- Newly diagnosed HCC either clinically in accordance with the version 2026 Liver Imaging Reporting and Data System (LI-RADS) or pathologically via core-needle biopsy.
- Single BCLC 0/A HCC.
- 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.
Key exclusion criteria (28 listed)
- Inadequate image quality for reliable analyses (e.g., severe artifact, incomplete images).
- Imaging evidence of tumor rupture at baseline.
- History of hepatic encephalopathy if clinically significant within one year prior to screening.
- Clinically symptomatic moderate-to-severe ascites.
- History of prior malignancy.
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 |
|---|---|---|
| ResectionHepatocellular 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. | Procedure or surgery | Curative Resection HCC Cohort |
Primary outcome
Recurrence-free Survival (RFS)
Time frame: From resection to the first documented recurrence or death from any cause, whichever occurs first, assessed up to 3 years.
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.
2 secondary outcomes
Overall Survival (OS)
Time frame: From resection to death from any cause, assessed up to 3 years
Time to recurrence (TTR)
Time frame: From resection to the first documented recurrence, assessed up to 3 years.
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 3 Nov 2026.
- 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?
An observational study of Resectable Hepatocellular Carcinoma (HCC), run by West China 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 21 inclusion and 28 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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.
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 Hanyu Jiang (+86 18608008770, hanyu_jiang@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (RFS) (time frame: From resection to the first documented recurrence or death from any cause, whichever occurs first, assessed up to 3 years.). 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 3 Nov 2026.