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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immuncell-LC | Biological | Activated T lymphocyte |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free Survival(RFS) | 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. | up to 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | 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). | up to 9 years |
| Cancer-specific Survivals(CSS) |
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Inclusion Criteria:
Exclusion Criteria:
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This long term follow-UP study is observation about the Immuncell-LC Groups' and 'Non-treatment Groups' in patient undergo curative resection (PEIT, RFA or Operation) for Hepatocelluar Carcinoma in Korea.
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| Name | Affiliation | Role |
|---|---|---|
| JinHee Kang | Global Product Development Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| No Interventions |
| Biological |
Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816). |
|
Cancer-specific survival was measured from the date of randomization until death resulting from HCC.
| up to 9 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |