Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620510
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Retrospective Study of Long-Term Survival of Immuncell-LC in Patients Undergoing Curative Resection for HCC in Korea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None