Trials / Completed
CompletedNCT01897610
Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC
Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- GC Cell Corporation · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.
Detailed description
* primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group * secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Immuncell-LC | intravenous dripping of 200ml(10\^9\~2x10\^10 lymphocytes/60kg adult) for 1 hour |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-04
- First posted
- 2013-07-12
- Last updated
- 2023-06-26
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01897610. Inclusion in this directory is not an endorsement.