Hepatocellular Carcinoma
Conditions
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.
Interventions
BIOLOGICALImmuncell-LC
Activated T lymphocyte
BIOLOGICALNo Interventions
Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).
Sponsors
GC Cell Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial.
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed