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

GC Cell

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Biological: No Interventions; Biological: Immuncell-LC

Study type: Observational

Funder types: Industry

Identifiers

NCT06620510

IIC-I03

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• NA

Trial design

230 participants in 2 patient groups

No intervention

Description:

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

Treatment:

Biological: No Interventions

Immuncell-LC Group

Description:

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

Treatment:

Biological: Immuncell-LC