The Study Collect Clinical Data From the Treatment of Liv... | NCT07233759

Studies
The Study Collect Clinical Data From the Treatment of Liver Cancer With New Drugs After 2019 and Integrate Biochemical and Pathological Indicators to Analyze Prognostic Outcomes, Including Overall Survival, Progression-free Survival, and Complications.

NCT07233759

Sponsor

National Taiwan University Hospital

Status

Active, not recruiting

Last Update Posted

Nov 18, 2025Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Liver Cancer
Pembrolizumab
Atezolizumab
Lenvatinib

Interventions

Not provided

Countries

Taiwan

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

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 1, 2025

First Submission Date that Met QC Criteria

Nov 16, 2025

First Posted Date

Nov 18, 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

Nov 16, 2025

Last Update Posted Date

Nov 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Hepatocellular carcinoma (HCC) is one of the most significant cancers in our country. Since 2019, many first-line and second-line therapeutic agents for HCC have been introduced. This study aims to evaluate the treatment outcomes of HCC patients in our hospital from 2019 to 2024 who received therapies other than the traditional sorafenib (Nexavar). The included drugs are Pembrolizumab, Atezolizumab (Tecentriq), Nivolumab, Lenvatinib, and Regorafenib (Stivarga). The study will collect clinical data from treated-cases with these novel agents after 2019 and integrate biochemical and pathological indicators to analyze prognostic outcomes, including overall survival, progression-free survival, and complications.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
liver cancer response of evaluation according to RECIST and mRECIST criteria		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hepatocellular carcinoma participants who received treatment at National Taiwan University Hospital between January 1, 2019, and June 30, 2026, and had used the following medications.
1. Pembrolizumab /keytruda
2. Atezolizumab / Tecentriq
3. Nivolumab
4. Lenvatinib
5. Stivarga
  
  Exclusion Criteria:
None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hepatocellular carcinoma participants who received treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

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

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D008107	Liver Diseases