Downstaging Prediction Model for HCC | NCT07058649

Studies
Downstaging Prediction Model for HCC

NCT07058649

Sponsor

Beijing Tsinghua Chang Gung Hospital

Status

Not yet recruiting

Last Update Posted

Jul 10, 2025Actual

Enrollment

369Estimated

Phase

Not provided

Conditions

HCC - Hepatocellular Carcinoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2025Estimated

Primary Completion Date

Oct 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Jul 1, 2025

First Submission Date that Met QC Criteria

Jul 1, 2025

First Posted Date

Jul 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2025

Last Update Posted Date

Jul 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

369Estimated

Label	Type	Description	Intervention Names
Successful downstaging		Failure downstaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HCC patients beyond UCSF criteria

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided