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

Not yet recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: No Interventions; Biological: Immuncell-LC

• Registration Number: NCT06620510
• Lead Sponsor: GC Cell Corporation

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-29
• Last Update Submitted: 2024-09-29
• Study Start: 2024-09-30
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No intervention	No Interventions	Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).
Immuncell-LC Group	Immuncell-LC	Patients who were in Immuncell-LC group in phase 3 clinical trial IIC-I01(NCT00699816).

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival(RFS)	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 Outcome Measures

Name	Time	Method
Overall Survival(OS)	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).
Cancer-specific Survivals(CSS)	up to 9 years	Cancer-specific survival was measured from the date of randomization until death resulting from HCC.