NCT06620510

Brief Summary

To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular carcinoma in Korea

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
Last Updated

August 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

September 26, 2024

Last Update Submit

August 13, 2025

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival(RFS)

    RFS was measured from the date of randomization to the first recurrence or to death from any cause. Radiological test should be operated by dynamic CT, dynamic MRI or by angiography.

    up to 9 years

Secondary Outcomes (2)

  • Overall Survival(OS)

    up to 9 years

  • Cancer-specific Survivals(CSS)

    up to 9 years

Study Arms (2)

No intervention

Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).

Biological: No Interventions

Immuncell-LC Group

Patients who were in Immuncell-LC group in phase 3 clinical trial IIC-I01(NCT00699816).

Biological: Immuncell-LC

Interventions

Immuncell-LCBIOLOGICAL

Activated T lymphocyte

Immuncell-LC Group
No InterventionsBIOLOGICAL

Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).

No intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This long term follow-UP study is observation about the Immuncell-LC Groups' and 'Non-treatment Groups' in patient undergo curative resection (PEIT, RFA or Operation) for Hepatocelluar Carcinoma in Korea.

You may qualify if:

  • Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • JinHee Kang

    Global Product Development Division

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 1, 2024

Study Start

September 30, 2024

Primary Completion

December 5, 2024

Study Completion

June 13, 2025

Last Updated

August 15, 2025

Record last verified: 2025-06

Locations

KR(1)