Inter-Individual Tumor Heterogeneity on 3D-MRE for Predicting Response to Conversion Therapy in Liver Cancer

NCT07716345 | Not Yet Recruiting

• 1 other identifier: XJTUSAH-MRE-003
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline (pre-treatment); surgical pathology if resection is performed

• Surgical Conversion Rate

  Up to 6 months after conversion therapy initiation

• Predictive accuracy (AUC) of baseline 3D-MRE parameters for treatment response

  Baseline through 12 weeks

Interventions

Three-Dimensional Magnetic Resonance Elastography DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Kai Qu

CONTACT

+8613609117104; qukai001@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07