Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-11 @ 7:00 AM
Study NCT ID:
NCT03592706
Status:
UNKNOWN
Last Update Posted:
2020-04-16
First Post:
2018-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
Sponsor:
Ivy Life Sciences, Co., Ltd
Organization:
Study Overview
Official Title:
A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in：
1. Reduction of tumor size
2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.
1. Reduction of tumor size
2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.
Detailed Description:
This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.
60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.
60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
NCT ID Aliases
| NCT ID Alias | NCT ID | View |
|---|---|---|
| None | NCT03592706 | View |