NCT07417800 Construction and Clinical Validation of a Predictive Model for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Based on Whole-Slide Digital Pathological Images and Deep Learning
| NCT ID | NCT07417800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 11,000 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 11,000 participants in total. It began in 2025-11-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hepatocellular carcinoma (HCC) is a high-mortality global malignancy with a heavy disease burden in China. Although curative surgical resection improves survival for early-stage HCC patients, the 5-year postoperative recurrence rate remains as high as 50%-70%. Postoperative adjuvant TACE and systemic TKIs are standard treatments for high-risk HCC, yet both therapies have prominent drawbacks, including limited response rates, unavoidable toxicities, and inconsistent clinical benefits. Current treatment decisions rely on conventional clinical and pathological features without precise biomarkers, leading to inadequate individualized therapy and wasted medical resources. Tumor immune microenvironment and multimodal imaging-pathological features critically determine HCC treatment sensitivity. Artificial intelligence and deep learning based on preoperative radiomics and postoperative H\&E whole-slide imaging (WSI) can capture hidden tumor biological characteristics and predict therapeutic responses. However, no validated multimodal AI model is available for predicting postoperative TACE and TKI treatment outcomes in HCC, lacking large-scale multicenter prospective evidence. This study aims to construct and validate a multimodal deep learning model integrating preoperative contrast-enhanced CT/MRI, postoperative WSI, pathological reports, and clinical data, to precisely identify HCC patients sensitive to postoperative adjuvant TACE or TKI therapy and optimize individualized treatment strategies. This is a hybrid retrospective-training and prospective observational multicenter study with no clinical intervention. A total of 10,000 retrospective HCC surgical patients will be enrolled to develop an AI classification model for predicting responses to four postoperative treatment strategies: surgery alone, surgery plus TACE, surgery plus TACE combined with systemic therapy, and surgery plus exclusive systemic therapy. Subsequently, 1,000 eligible postoperative HCC patients will be prospectively and consecutively enrolled from 10-15 centers. The AI model will generate adjuvant therapy predictions without interfering with real clinical decisions. Patients will be divided into prediction-consistent and prediction-inconsistent cohorts based on the match between model predictions and actual treatments. Long-term follow-up will be performed to compare prognostic outcomes and validate the model's real-world performance and stability. Key inclusion criteria: histopathologically confirmed HCC; aged 18-75 years; received R0 curative resection; available qualified H\&E-stained FFPE slides for digital scanning; complete clinical, pathological and follow-up data; high-quality preoperative contrast-enhanced CT/MRI images eligible for AI analysis. Key exclusion criteria: prior preoperative anti-tumor therapy with unavailable baseline data; concurrent other primary malignancies; non-R0 resection; unqualified pathological slides or imaging data; severe missing clinical or follow-up information.
Eligibility Criteria
Inclusion Criteria: * Histopathologically confirmed hepatocellular carcinoma; * Aged more than 18 years; * Underwent radical resection of primary liver cancer (R0 resection); * Availability of postoperative H\&E-stained paraffin embedded tissue sections suitable for digital whole-slide imaging; * Had complete and accessible clinicopathological data and follow-up data; * Has complete and evaluable preoperative and postoperative contrast-enhanced CT or MRI imaging with standardized scanning parameters and no severe artifacts, meeting the quality requirements for radiomic and artificial intelligence analysis. Exclusion Criteria: * Significant missing clinical or follow-up data; * Concurrent primary malignancy in other organs; * Positive surgical margin (R1 or R2 resection); * Tissue sections of poor quality (e.g., severe fading, folding, damage) unsuitable for digital scanning or analysis;
Contact & Investigator
ding yuan, doctor
STUDY CHAIR
Second Affiliated Hospital, Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT07417800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07417800 currently recruiting?
Yes, NCT07417800 is actively recruiting participants. Contact the research team at dingyuan@zju.edu.cn for enrollment information.
Where is the NCT07417800 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07417800 clinical trial?
NCT07417800 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is ding yuan, doctor at Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 11,000 participants.
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