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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Immuncell-LC

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring Immuncell-LC, advanced hepatocellular carcinoma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Inha University Hospital
Yonsei University Health System
Korea University Anam Hospital
The Catholic University of Korea, Seoul ST. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

Immuncell-LC group

Arm Description

The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.

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).

Outcomes

Primary Outcome Measures

To assess progression-free survival (PFS)

CT, PET-CT, MRI

Secondary Outcome Measures

To assess the overall survival (OS)

To evaluate the Disease control rate

to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST

To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date

analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC

Number of participants with adverse events

Full Information

NCT ID

NCT01897610

First Posted

June 25, 2013

Last Updated

June 22, 2023

Sponsor

GC Cell Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01897610

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GC Cell Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocellular Carcinoma

Keywords

Immuncell-LC, advanced hepatocellular carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.

Arm Title

Immuncell-LC group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Immuncell-LC

Other Intervention Name(s)

Activated T lymphocyte

Intervention Description

intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour

Primary Outcome Measure Information:

Title

To assess progression-free survival (PFS)

Description

CT, PET-CT, MRI

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

To assess the overall survival (OS)

Time Frame

up to 2 years

Title

To evaluate the Disease control rate

Description

to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST

Time Frame

up to 2 years

Title

To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date

Description

analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC

Time Frame

up to 2 years

Title

Number of participants with adverse events

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soon Ho Um, MD, PhD

Organizational Affiliation

Korea University Anam Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inha University Hospital

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

Yonsei University Health System

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital

City

Seoul

ZIP/Postal Code

136-750

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul ST. Mary's Hospital

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

12394214

Citation

Di Maio M, De Maio E, Perrone F, Pignata S, Daniele B. Hepatocellular carcinoma: systemic treatments. J Clin Gastroenterol. 2002 Nov-Dec;35(5 Suppl 2):S109-14. doi: 10.1097/00004836-200211002-00007.

Results Reference

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PubMed Identifier

15195890

Citation

Ganne-Carrie N, Trinchet JC. Systemic treatment of hepatocellular carcinoma. Eur J Gastroenterol Hepatol. 2004 Mar;16(3):275-81. doi: 10.1097/00042737-200403000-00005.

Results Reference

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PubMed Identifier

19095497

Citation

Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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

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