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

NCT ID: NCT06620510

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-06-13

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

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

No intervention

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

No Interventions

Intervention Type: BIOLOGICAL

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

Immuncell-LC Group

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

Immuncell-LC

Intervention Type: BIOLOGICAL

Activated T lymphocyte

Interventions

Immuncell-LC

Activated T lymphocyte

Intervention Type: BIOLOGICAL

No Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• NA

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GC Cell Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JinHee Kang

Role: STUDY_DIRECTOR

Global Product Development Division

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

IIC-I03

Identifier Type: -

Identifier Source: org_study_id