Trials / Unknown
UnknownNCT03592706
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
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
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Ivy Life Sciences, Co., Ltd · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IKC (Immune Killer Cells) | |
| PROCEDURE | TACE (Transcatheter Arterial Chemoembolization) |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2021-02-01
- Completion
- 2021-08-01
- First posted
- 2018-07-19
- Last updated
- 2020-04-16
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03592706. Inclusion in this directory is not an endorsement.