Downstaging Prediction Model for HCC

Not yet recruiting

• Conditions: HCC - Hepatocellular Carcinoma

• Registration Number: NCT07058649
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

This study is a real-world, single-center study that collects imaging and clinical data from patients with HCC who are downstaged beyond the UCSF criteria.

Detailed Description

This study is a real-world, single-center study that collects imaging and clinical data from patients with HCC who are downstaged beyond the UCSF criteria. It constructs a predictive model for downstaging treatment of liver cancer beyond the UCSF standards and completes external validation. This model will assist in clinical decision-making for the downstaging treatment of liver cancer beyond the UCSF criteria. Further downstaging methods are stratified to guide the selection of individualized downstaging treatment options for liver cancer beyond the UCSF standards.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Study Start: 2025-07-16
• Primary Completion: 2027-10-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

• (A) Adult patients with HCC over the age of 18 (clinically diagnosed or pathologically diagnosed); (B) Liver function Child-Pugh score of Class A, or Class B with a score of 7 or below (including 7); (C) A single solid tumor with a diameter of ≥6.5 cm; three or more lesions, among which at least one tumor has a diameter >4.5 cm or the sum of the diameters is ≥8 cm; invasion of major blood vessels regardless of tumor size and number.

Exclusion Criteria

• (A) Presence of distant metastasis outside the liver; (B) General performance status score (PS score) greater than 2 points.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Downstagingoutcomes	3 months after downstaging	Successful downstaging is defined by meeting the UCSF criteria after downstaging; no invasion of the main trunk of the portal vein or the main trunk of the hepatic vein; and no lymph node invasion. The evaluation criteria used for interpretation are the mRECIST (modified Response Evaluation Criteria in Solid Tumors) standards.