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Completed

NCT Number: NCT06620510

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • NA

Treatment and study plan

Immuncell-LC

Biological

Activated T lymphocyte

No Interventions

Biological

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

Primary outcomes

  1. Recurrence-free Survival(RFS)

    Time frame: up to 9 years

    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.

Secondary outcomes

  1. Overall Survival(OS)

    Time frame: up to 9 years

    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).

  2. Cancer-specific Survivals(CSS)

    Time frame: up to 9 years

    Cancer-specific survival was measured from the date of randomization until death resulting from HCC.

Sponsors and collaborators

Lead sponsor

GC Cell Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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