Retrospective Study of Long-Term Survival of "Immuncell-LC" in Patients Undergoing Curative Resection for HCC in Korea

A Multicenter, Retrospective Data Analysis Study on the Long-term Survival Rate of the 'Immuncell-LC Goups' and 'Non-treatment Groups' in Patient Undergo Curative Resection (PEIT, RFA or Operation) for Hepatocellular Carcinoma in Korea

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

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Biological: Immuncell-LC; Biological: No Interventions

Detailed Description

The purpose of this study is to retrospectively compare the long-term survival of patients who participated in the "Randomized, open-label, multicenter phase 3 clinical trial to evaluate the efficacy and safety of Immunocel-LC treatment and no treatment in Korean patients with hepatocellular carcinoma (HCC) who received potentially curative treatment [surgical resection, radiofrequency ablation (RFA), or percutaneous ethanol injection (PEI)] (NCT00699816). HCC was diagnosed by pathological evaluation or radiological imaging studies. Eligibility criteria also included hepatic function of Child-Pugh class A and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Exclusion criteria included autoimmune disease or immunodeficiency, previous or current malignant tumor other than HCC, and severe allergic disorders. Pregnant or breastfeeding women and women planning to become pregnant were also excluded. All eligible participants were randomly assigned to receive adjuvant immunotherapy using a CIK cell agent (the immunotherapy group) or no adjuvant treatment (control group) in a 1:1 ratio.

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immuncell-LC Group; Patients who were in Immuncell-LC group in phase 3 clinical trial IIC-I01(NCT00699816).	Biological: Immuncell-LC; Activated T lymphocyte
No intervention; Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).	Biological: No Interventions; Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival(OS)	Overall survival was measured from the date of randomization until death from any cause. And OS was estimated using Kaplan-Meier methods with 95% confidence intervals (CIs).	up to 9 years
Cancer-specific Survivals(CSS)	Cancer-specific survival was measured from the date of randomization until death resulting from HCC.	up to 9 years

Collaborators and Investigators

• Sponsor: GC Cell Corporation
• Investigators: Study Director: JinHee Kang, Global Product Development Division

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: IIC-I03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No