A Multicenter, Retrospective Data Analysis Study on the Long-term Survival Rate of the 'Immuncell-LC Goups' and 'Non-treatment Groups' in Patient Undergo Curative Resection (PEIT, RFA or Operation) for Hepatocellular Carcinoma in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival(RFS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial.
排除标准
- 未提供
研究组 & 干预措施
No intervention
Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).
干预措施: No Interventions (Biological)
Immuncell-LC Group
Patients who were in Immuncell-LC group in phase 3 clinical trial IIC-I01(NCT00699816).
干预措施: Immuncell-LC (Biological)
结局指标
主要结局
Recurrence-free Survival(RFS)
时间窗: 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.
次要结局
- Overall Survival(OS)(up to 9 years)
- Cancer-specific Survivals(CSS)(up to 9 years)
