ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 6 for:    19095497 [PUBMED-IDS]

Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01897610
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Drug: Immuncell-LC Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: control group
The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.
Experimental: Immuncell-LC group
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after baseline by administering Nexavar chemotherapy same as control group with Immuncell-LC (10 times).
Drug: Immuncell-LC
intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour
Other Name: Activated T lymphocyte




Primary Outcome Measures :
  1. To assess progression-free survival (PFS) [ Time Frame: up to 2 years ]
    CT, PET-CT, MRI


Secondary Outcome Measures :
  1. To assess the overall survival (OS) [ Time Frame: up to 2 years ]
  2. To evaluate the Disease control rate [ Time Frame: up to 2 years ]
    to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST

  3. To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date [ Time Frame: up to 2 years ]
    analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC

  4. Number of participants with adverse events [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have consented to the study by providing signature of self, guardian or legal representative
  • The patient is more than 20 and less than 80 years old
  • The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV
  • Child-Pugh Score should be A
  • ECOG Performance Status (ECOG-PS) is less than 2 or equal to
  • Patients who receiving or ready for Nexavar treatment
  • Patients who satisfy the following conditions of the blood test and kidney function test

    • Absolute granulocyte count is bigger than 1,000/µL
    • Hemoglobin is bigger than 8.5 g/dL
    • Platelet count is bigger than 5x10^10/L
    • Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit

Exclusion Criteria:

  • Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
  • Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer.
  • Patients who had anti-cancer medication before the study with the exception of Nexavar
  • Patients who has serious dysfunction in other organs by sub-investigator's opinion
  • Patients has serious allergic-history by sub-investigator's opinion
  • Patients has serious mental disease sub-investigator's opinion
  • Pregnant women, nursing mother of having intention of being pregnant during the study
  • Patients who participated in other clinical trial within 4 weeks before this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897610


Locations
Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-750
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
Principal Investigator: Soon Ho Um, MD, PhD Korea University Anam Hospital

Publications:

Responsible Party: Green Cross Cell Corporation
ClinicalTrials.gov Identifier: NCT01897610     History of Changes
Other Study ID Numbers: ILC-IIT-04
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: March 2016

Keywords provided by Green Cross Cell Corporation:
Immuncell-LC, advanced hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action