Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT00699816

Recruitment Status : Completed

First Posted : June 18, 2008

Results First Posted : September 24, 2015

Last Update Posted : October 26, 2017

Sponsor:

Information provided by (Responsible Party):

GC Cell Corporation

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Hepatocellular Carcinoma
Intervention	Biological: Immuncell-LC
Enrollment	230

Participant Flow

Recruitment Details	This phase 3 clinical study was a multicenter, randomized, open-labeled trial. The study was conducted at 5 university affiliated hospitals in Korea. All eligible participants were assigned randomly, in a 1:1 ratio, to receive adjuvant adoptive immune therapy using a CIK cell agent or no adjuvant treatment.
Pre-assignment Details


Arm/Group Title	Immunotherapy Group	Control Group
Arm/Group Description	Patients who had undergone curative...	Patients who had undergone curative...
Arm/Group Description	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Period Title: Overall Study
Started	115	115
Completed	114	112
Not Completed	1	3
Reason Not Completed
Protocol Violation	1	3

Baseline Characteristics

Arm/Group Title		Immunotherapy Group	Control Group	Total
Arm/Group Description		Patients who had undergone curative...	Patients who had undergone curative...	Total of all reporting groups
Arm/Group Description		Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment	Total of all reporting groups
Overall Number of Baseline Participants		114	112	226
Baseline Analysis Population Description		...
Baseline Analysis Population Description		A total of 230 eligible participants were assigned randomly to either the immunotherapy group(n=115) or the control group(n=115). Among these randomized patients, 226(114 in the immunotherapy group and 112 in the control group) were included in the efficacy analysis. 4 patients were excluded due to violation of the inclusion and exclusion criteria.
Age, Customized Mean (Standard Deviation) Unit of measure: Years
Age	Number Analyzed	114 participants	112 participants	226 participants
Age		55.4 (8.2)	56.4 (10.6)	55.9 (9.4)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	114 participants	112 participants	226 participants
	Female	19 16.7%	21 18.8%	40 17.7%
	Male	95 83.3%	91 81.3%	186 82.3%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Korea, Republic of	Number Analyzed	114 participants	112 participants	226 participants
Korea, Republic of		114	112	226
Treatment modality Measure Type: Number Unit of measure: Participants	Number Analyzed	114 participants	112 participants	226 participants
Percutaneous ethanol injection		13	4	17
Radiofrequency ablation		69	70	139
Surgical resection		32	38	70
HCC stage ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	114 participants	112 participants	226 participants
Stage I		98	94	192
Stage II		16	18	34
		[1] Measure Description: HCC staging criteria is AJCC staging system(6th edition) developed by the American Joint Committee on Cancer for describing the extent of disease progression in cancer patients. It utilizes in part the TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. The TNM Staging System is based on the extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M). Once the T, N, and M are determined, they are combined, and an overall "Stage" of I, II, III, IV is assigned. Higher stage cancers are more advanced.
Number of HCC ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	114 participants	112 participants	226 participants
>3 or =3		2	2	4
<3		112	110	222
		[1] Measure Description: Tumor assessments were performed using dynamic computed tomography or magnetic resonance imaging. All scans were reviewed by 2 independent radiologists at each site(hospital) with more than 5 years' experience, who were unaware of the group assignment. In cases of discordance, an additional third independent experienced radiologist reviewed images and consensus was achieved among the 3 radiologists.
Size of HCC ^[1] Median (Inter-Quartile Range) Unit of measure: Centimeter
	Number Analyzed	114 participants	112 participants	226 participants
		1.8 (1.4 to 2.3)	2.3 (1.5 to 3.1)	2.0 (1.4 to 2.7)
		[1] Measure Description: Tumor assessments were performed using dynamic computed tomography or magnetic resonance imaging. All scans were reviewed by 2 independent radiologists at each site(hospital) with more than 5 years' experience, who were unaware of the group assignment. In cases of discordance, an additional third independent experienced radiologist reviewed images and consensus was achieved among the 3 radiologists.
ECOG performance status ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	114 participants	112 participants	226 participants
0		81	81	162
1		33	31	64
		[1] Measure Description: ECOG (Eastern Cooperative Oncology Group) performance status assesses the daily living abilities of the patient, on a scale ranging from 0(fully active) to 5(dead).
Cause of liver disease Measure Type: Number Unit of measure: Participants	Number Analyzed	114 participants	112 participants	226 participants
HBV infection only		96	90	186
HCV infection only		9	10	19
HBV and HCV		2	2	4
Co-infection (Others)		7	10	17
Co-infection (Cirrhosis)		76	70	146
Alpha fetoprotein level Median (Inter-Quartile Range) Unit of measure: ng/mL
	Number Analyzed	114 participants	112 participants	226 participants
		5.2 (3.1 to 9.9)	5.4 (3.0 to 13.0)	5.3 (3 to 11.4)
PIVKA-II Median (Inter-Quartile Range) Unit of measure: mAU/mL
	Number Analyzed	114 participants	112 participants	226 participants
		19.0 (14.0 to 24.8)	18.0 (14.0 to 24.0)	18.5 (14 to 24.4)
Aspartate aminotransferase level Median (Inter-Quartile Range) Unit of measure: IU/L
	Number Analyzed	114 participants	112 participants	226 participants
		33.0 (27.0 to 43.5)	34.0 (26.8 to 44.0)	33.5 (26.9 to 43.8)
Alanine aminotransferase level Median (Inter-Quartile Range) Unit of measure: IU/L
	Number Analyzed	114 participants	112 participants	226 participants
		33.0 (25.0 to 45.8)	33.0 (23.0 to 47.5)	33.0 (24.0 to 46.7)
Alkaline phosphatase level Median (Inter-Quartile Range) Unit of measure: IU/L
	Number Analyzed	114 participants	112 participants	226 participants
		82.5 (70.0 to 101.5)	82.0 (65.0 to 100.0)	82.3 (67 to 100.3)
Albumin level Median (Inter-Quartile Range) Unit of measure: g/dL
	Number Analyzed	114 participants	112 participants	226 participants
		4.1 (3.9 to 4.3)	4.1 (3.9 to 4.3)	4.1 (3.9 to 4.3)
Total bilirubin level Median (Inter-Quartile Range) Unit of measure: mg/dL
	Number Analyzed	114 participants	112 participants	226 participants
		0.8 (0.6 to 1.0)	0.8 (0.6 to 1.0)	0.8 (0.6 to 1.0)
Prothrombin time Median (Inter-Quartile Range) Unit of measure: Seconds
	Number Analyzed	114 participants	112 participants	226 participants
		13.7 (13.1 to 14.7)	13.9 (13.2 to 14.4)	13.8 (13.2 to 14.6)
Creatinine level Median (Inter-Quartile Range) Unit of measure: mg/dL
	Number Analyzed	114 participants	112 participants	226 participants
		0.9 (0.8 to 1.0)	0.9 (0.7 to 1.0)	0.9 (0.8 to 1.0)
Platelet Median (Inter-Quartile Range) Unit of measure: X 10^3/mm^3
	Number Analyzed	114 participants	112 participants	226 participants
		116.5 (92.3 to 158.0)	141.0 (117.5 to 166.3)	128.6 (100.0 to 157.2)

Outcome Measures

1.Primary Outcome


Title	Recurrence Free Survival(RFS)
Description	RFS was measured from the date of randomization to the first recurrenc...
Description	RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Time Frame	Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Immunotherapy Group	Control Group
Arm/Group Description:	Patients who had undergone curative...	Patients who had undergone curative...
Arm/Group Description:	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed	114	112
Median (95% Confidence Interval) Unit of Measure: months
	44.0 (42.46 to 44.54)	30.0 (28.25 to 31.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Immunotherapy Group, Control Group
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95% 0.43 to 0.94
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Recurrence Free Survival(RFS) Rate
Description	RFS rate was measured from the date of randomization to the first recu...
Description	RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.
Time Frame	Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Immunotherapy Group	Control Group
Arm/Group Description:	Patients who had undergone curative...	Patients who had undergone curative...
Arm/Group Description:	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed	114	112
Measure Type: Number Unit of Measure: percentage of participants
RFS rate 12 months	79.9	65.1
RFS rate 24 months	72.5	53.8
RFS rate 36 months	60.9	44.3
RFS rate 48 months	49.6	39.6

3.Secondary Outcome


Title	Overall Survival(OS)
Description	Overall survival was measured from the date of randomization until dea...
Description	Overall survival was measured from the date of randomization until death from any cause.
Time Frame	Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Immunotherapy Group	Control Group
Arm/Group Description:	Patients who had undergone curative...	Patients who had undergone curative...
Arm/Group Description:	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed	114	112
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median OS was not reached.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Immunotherapy Group, Control Group
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.008
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95% 0.06 to 0.75
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Cancer-specific Survivals
Description	Cancer-specific survival was measured from the date of randomization u...
Description	Cancer-specific survival was measured from the date of randomization until death resulting from HCC.
Time Frame	Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Immunotherapy Group	Control Group
Arm/Group Description:	Patients who had undergone curative...	Patients who had undergone curative...
Arm/Group Description:	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed	114	112
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median Cancer-specific survival was not reached.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Immunotherapy Group, Control Group
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95% 0.04 to 0.87
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Overall Survival(OS) Rate
Description	Overall survival rate was measured from the date of randomization unti...
Description	Overall survival rate was measured from the date of randomization until death from any cause.
Time Frame	Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Immunotherapy Group	Control Group
Arm/Group Description:	Patients who had undergone curative...	Patients who had undergone curative...
Arm/Group Description:	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed	114	112
Measure Type: Number Unit of Measure: percentage of participants
OS rate 12 months	100.0	98.0
OS rate 24 months	100.0	91.8
OS rate 36 months	97.5	88.1
OS rate 48 months	95.9	84.8

6.Secondary Outcome


Title	Cancer-specific Survival Rate
Description	Cancer-specific survival rate was measured from the date of randomizat...
Description	Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.
Time Frame	Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Immunotherapy Group	Control Group
Arm/Group Description:	Patients who had undergone curative...	Patients who had undergone curative...
Arm/Group Description:	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed	114	112
Measure Type: Number Unit of Measure: percentage of participants
Cancer-specific survival rate 12 months	100.0	98.0
Cancer-specific survival rate 24 months	100.0	94.9
Cancer-specific survival rate 36 months	98.8	91.0
Cancer-specific survival rate 48 months	97.2	87.5

Adverse Events

Time Frame	Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Immunotherapy Group		Control Group
Arm/Group Description	Patients who had undergone curative...		Patients who had undergone curative...
Arm/Group Description	Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent		Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
All-Cause Mortality
	Immunotherapy Group		Control Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Immunotherapy Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/115 (7.83%)		4/115 (3.48%)
Ear and labyrinth disorders
Sudden hearing loss ^* 1	0/115 (0.00%)	0	1/115 (0.87%)	1
Gastrointestinal disorders
Gastric ulcer ^* 1	0/115 (0.00%)	0	1/115 (0.87%)	1
Oesophageal varices haemorrhage ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Haemorrhoids ^* 1	0/115 (0.00%)	0	1/115 (0.87%)	1
Hepatobiliary disorders
Hepatic vein stenosis ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Infections and infestations
Herpes zoster ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Injury, poisoning and procedural complications
Laceration ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Meniscus lesion ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Humerus fracture ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Foot fracture ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Gastric adenoma ^* 1	0/115 (0.00%)	0	1/115 (0.87%)	1
Surgical and medical procedures
High frequency ablation ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAE (3.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Immunotherapy Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	71/115 (61.74%)		47/115 (40.87%)
Ear and labyrinth disorders
Sudden hearing loss ^* 1	0/115 (0.00%)	0	1/115 (0.87%)	1
Gastrointestinal disorders
Abdominal pain upper ^* 1	2/115 (1.74%)	2	5/115 (4.35%)	5
Nausea ^* 1	3/115 (2.61%)	3	1/115 (0.87%)	1
Vomiting ^* 1	3/115 (2.61%)	3	3/115 (2.61%)	4
Dyspepsia ^* 1	6/115 (5.22%)	6	4/115 (3.48%)	4
Epigastric discomfort ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Gastritis erosive ^* 1	1/115 (0.87%)	1	2/115 (1.74%)	2
Abdominal pain ^* 1	2/115 (1.74%)	4	2/115 (1.74%)	3
Gastritis ^* 1	0/115 (0.00%)	0	3/115 (2.61%)	3
Gastric polyps ^* 1	0/115 (0.00%)	0	3/115 (2.61%)	3
Gastric ulcer ^* 1	1/115 (0.87%)	1	2/115 (1.74%)	3
Constipation ^* 1	3/115 (2.61%)	4	2/115 (1.74%)	2
Haemorrhoids ^* 1	1/115 (0.87%)	1	3/115 (2.61%)	3
General disorders
Chills ^* 1	11/115 (9.57%)	24	0/115 (0.00%)	0
Pyrexia ^* 1	12/115 (10.43%)	22	0/115 (0.00%)	0
Fatigue ^* 1	11/115 (9.57%)	12	3/115 (2.61%)	3
Asthenia ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Chest discomfort ^* 1	3/115 (2.61%)	3	0/115 (0.00%)	0
Infections and infestations
Upper respiratory tract infection ^* 1	6/115 (5.22%)	6	4/115 (3.48%)	5
Body tinea ^* 1	0/115 (0.00%)	0	1/115 (0.87%)	1
Herpes zoster ^* 1	2/115 (1.74%)	2	0/115 (0.00%)	0
Injury, poisoning and procedural complications
Laceration ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Foot fracture ^* 1	1/115 (0.87%)	1	1/115 (0.87%)	1
Humerus fracture ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Investigations
Alanine aminotransferase increased ^* 1	2/115 (1.74%)	2	1/115 (0.87%)	1
Weight decreased ^* 1	0/115 (0.00%)	0	3/115 (2.61%)	3
Weight increased ^* 1	2/115 (1.74%)	3	0/115 (0.00%)	0
Metabolism and nutrition disorders
Hyperuricaemia ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Musculoskeletal and connective tissue disorders
Myalgia ^* 1	5/115 (4.35%)	6	0/115 (0.00%)	0
Back pain ^* 1	2/115 (1.74%)	3	1/115 (0.87%)	1
Flank pain ^* 1	3/115 (2.61%)	3	1/115 (0.87%)	1
Nervous system disorders
Dizziness ^* 1	5/115 (4.35%)	5	3/115 (2.61%)	3
Headache ^* 1	3/115 (2.61%)	4	1/115 (0.87%)	1
Psychiatric disorders
Insomnia ^* 1	1/115 (0.87%)	1	3/115 (2.61%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^* 1	1/115 (0.87%)	1	1/115 (0.87%)	1
Productive cough ^* 1	6/115 (5.22%)	6	0/115 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermatitis acneiform ^* 1	0/115 (0.00%)	0	2/115 (1.74%)	2
Pruritus ^* 1	5/115 (4.35%)	5	4/115 (3.48%)	4
Dermatitis ^* 1	1/115 (0.87%)	1	0/115 (0.00%)	0
Vascular disorders
Hypertension ^* 1	2/115 (1.74%)	2	2/115 (1.74%)	2
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAE (3.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Jung-Hwan Yoon, MD, PhD
Organization:	Seoul National University College of Medicine
Phone:	+82-2-2072-2228
EMail:	yoonjh@snu.ac.kr

Publications:

Takayama T, Sekine T, Makuuchi M, Yamasaki S, Kosuge T, Yamamoto J, Shimada K, Sakamoto M, Hirohashi S, Ohashi Y, Kakizoe T. Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet. 2000 Sep 2;356(9232):802-7. Erratum in: Lancet 2000 Nov 11;356(9242):1690.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.

Layout table for additonal information

Responsible Party:	GC Cell Corporation
ClinicalTrials.gov Identifier:	NCT00699816
Other Study ID Numbers:	IIC-I01
First Submitted:	June 17, 2008
First Posted:	June 18, 2008
Results First Submitted:	June 18, 2015
Results First Posted:	September 24, 2015
Last Update Posted:	October 26, 2017

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