Hepato Cellular CarcinomaNCT07716345
Inter-Individual Tumor Heterogeneity on 3D-MRE for Predicting Response to Conversion Therapy in Liver Cancer
An observational study of Hepato Cellular Carcinoma and Intrahepatic Bile Duct Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial summary
How to predict which patients with initially unresectable liver cancer are more likely to respond to conversion therapy remains an important unresolved problem in guiding treatment strategy and surgical timing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma
- What is being tested?
- Three-Dimensional Magnetic Resonance Elastography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll adult patients with initially unresectable liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who are planned to receive conversion therapy at the Second Affiliated Hospital of Xi'an Jiaotong University, with the treatment goal of achieving surgical resectability. Eligible patients will undergo 3D-MRE examinations prior to conversion therapy. Patients will be consecutively recruited from the hepatobiliary oncology multidisciplinary team (MDT) of the study center prior to initiation of conversion therapy.
Who may be able to join
- Age 18-75 years
- Pathologically or radiologically confirmed diagnosis of initially unresectable liver cancer (hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis)
- Planned to receive conversion therapy with the intent of achieving surgical resectability
- Child-Pugh class A or B liver function (for patients with primary liver cancer)
- ECOG performance status 0-1
- At least one measurable lesion per RECIST 1.1
- Able to undergo 3D-MRE examination prior to conversion therapy
- Provision of signed and dated informed consent
Who cannot join
- Contraindication to MRI
- Child-Pugh class C liver function (for patients with primary liver cancer)
- Uncontrolled ascites, hepatic encephalopathy, or variceal bleeding within 3 months prior to enrollment
- Other concurrent active malignancy
- Severe comorbidities precluding conversion therapy or surgery
- Pregnant or breastfeeding women
- Anticipated poor compliance with repeated MRE examinations or follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study on Inter-Individual Tumor Heterogeneity Assessed by Three-Dimensional Magnetic Resonance Elastography for Predicting Response to Conversion Therapy in Patients With Liver Cancer
How to predict which patients with initially unresectable liver cancer are more likely to respond to conversion therapy remains an important unresolved problem in guiding treatment strategy and surgical timing. Substantial variation exists among patients in their tumor response to the same conversion therapy regimen, and current pretreatment imaging assessment does not adequately capture this inter-individual variability. We hypothesize that baseline tumor viscoelastic parameters measured by three-dimensional magnetic resonance elastography (3D-MRE) differ substantially across patients, and that this inter-individual heterogeneity may be associated with differential response to conversion therapy. This study aims to prospectively evaluate the association between baseline 3D-MRE-derived tumor viscoelastic parameters and pathological response as well as surgical conversion outcomes across patients with liver cancer receiving conversion therapy.
- Conditions
- Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma
- Being tested
- Three-Dimensional Magnetic Resonance Elastography
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Magnetic Resonance ElastographyDevice
Patients with initially unresectable liver cancer who are planned to receive conversion therapy will undergo a baseline three-dimensional magnetic resonance elastography (3D-MRE) examination prior to treatment initiation, in addition to standard-of-care evaluation. 3D-MRE will be used to quantify tumor viscoelastic parameters (including stiffness, storage modulus, loss modulus, and damping ratio) at baseline. These baseline imaging parameters will be compared across patients and analyzed for their association with subsequent pathological response and surgical conversion outcomes following conversion therapy. The examination does not alter the standard treatment regimen selected by the treating physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) after conversion therapy
Response evaluated according to RECIST 1.1 or mRECIST criteria based on imaging assessment after conversion therapy, analyzed in relation to baseline 3D-MRE parameters
Measured: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)
Secondary outcomes (3)
Association between baseline 3D-MRE parameters and pathological response
Correlation between baseline tumor stiffness (measured in kilopascals by three-dimensional magnetic resonance elastography) and pathological response status (major pathological response [≤10% residual viable tumor] vs. non-major pathological response, assessed by histopathological examination of the surgical specimen) in patients who undergo surgical resection following conversion therapy.
Measured: Baseline (pre-treatment); surgical pathology if resection is performed
Surgical Conversion Rate
Proportion of patients who successfully undergo surgical resection after conversion therapy
Measured: Up to 6 months after conversion therapy initiation
Predictive accuracy (AUC) of baseline 3D-MRE parameters for treatment response
Area under the receiver operating characteristic curve (AUC) for baseline 3D-MRE-derived tumor stiffness in predicting objective response (per RECIST 1.1 or mRECIST) to conversion therapy.
Measured: Baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular CarcinomaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716345
- Sponsor's protocol ID
- XJTUSAH-MRE-003
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Inter-Individual Tumor Heterogeneity Assessed by Three-Dimensional Magnetic Resonance Elastography for Predicting Response to Conversion Therapy in Patients With Liver Cancer
- ClinicalTrials.gov ID
- NCT07716345
- Acronym / sponsor ID
- XJTUSAH-MRE-003
- Conditions
- Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 21 Jul 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.
How to predict which patients with initially unresectable liver cancer are more likely to respond to conversion therapy remains an important unresolved problem in guiding treatment strategy and surgical timing. Substantial variation exists among patients in their tumor response to the same conversion therapy regimen, and current pretreatment imaging assessment does not adequately capture this inter-individual variability. We hypothesize that baseline tumor viscoelastic parameters measured by three-dimensional magnetic resonance elastography (3D-MRE) differ substantially across patients, and that this inter-individual heterogeneity may be associated with differential response to conversion therapy. This study aims to prospectively evaluate the association between baseline 3D-MRE-derived tumor viscoelastic parameters and pathological response as well as surgical conversion outcomes across patients with liver cancer receiving conversion therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll adult patients with initially unresectable liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who are planned to receive conversion therapy at the Second Affiliated Hospital of Xi'an Jiaotong University, with the treatment goal of achieving surgical resectability. Eligible patients will undergo 3D-MRE examinations prior to conversion therapy. Patients will be consecutively recruited from the hepatobiliary oncology multidisciplinary team (MDT) of the study center prior to initiation of conversion therapy.
Key inclusion criteria (8 listed)
- Age 18-75 years
- Pathologically or radiologically confirmed diagnosis of initially unresectable liver cancer (hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis)
- Planned to receive conversion therapy with the intent of achieving surgical resectability
- Child-Pugh class A or B liver function (for patients with primary liver cancer)
- ECOG performance status 0-1
Key exclusion criteria (7 listed)
- Contraindication to MRI
- Child-Pugh class C liver function (for patients with primary liver cancer)
- Uncontrolled ascites, hepatic encephalopathy, or variceal bleeding within 3 months prior to enrollment
- Other concurrent active malignancy
- Severe comorbidities precluding conversion therapy or surgery
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 |
|---|---|---|
| Three-Dimensional Magnetic Resonance ElastographyPatients with initially unresectable liver cancer who are planned to receive conversion therapy will undergo a baseline three-dimensional magnetic resonance elastography (3D-MRE) examination prior to treatment initiation, in addition to standard-of-care evaluation. 3D-MRE will be used to quantify tumor viscoelastic parameters (including stiffness, storage modulus, loss modulus, and damping ratio) at baseline. These baseline imaging parameters will be compared across patients and analyzed for their association with subsequent pathological response and surgical conversion outcomes following conversion therapy. The examination does not alter the standard treatment regimen selected by the treating physician. | Device | – |
Primary outcome
Objective Response Rate (ORR) after conversion therapy
Time frame: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)
Response evaluated according to RECIST 1.1 or mRECIST criteria based on imaging assessment after conversion therapy, analyzed in relation to baseline 3D-MRE parameters
3 secondary outcomes
Association between baseline 3D-MRE parameters and pathological response
Time frame: Baseline (pre-treatment); surgical pathology if resection is performed
Surgical Conversion Rate
Time frame: Up to 6 months after conversion therapy initiation
Predictive accuracy (AUC) of baseline 3D-MRE parameters for treatment response
Time frame: Baseline through 12 weeks
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 21 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato Cellular Carcinoma and Intrahepatic Bile Duct Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
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 7 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kai Qu (+8613609117104, qukai001@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) after conversion therapy (time frame: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)). 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 21 Jul 2026.