Downstaging Prediction Model for HCC

NCT07058649 | Not Yet Recruiting DMC

• 1 other identifier: 25288-0-02
• Study Type: observational
• Target: 369
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

downstaging; UCSF

Outcome Measures

Primary Outcomes (1)

• Downstagingoutcomes

  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.

  3 months after downstaging

Study Arms (1)

Successful downstaging

Failure downstaging

Eligibility Criteria

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

Study Population

HCC patients beyond UCSF criteria

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

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

Study Design

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

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07