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

Hepatocellular Carcinoma Clinical Trial

Official title:

Randomized, Open-label, Multi-center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of 'Green Cross CELL Immuncell-LC Group' and 'Non-treatment Group' in Patient Undergone Curative Resection(PEIT, RFA or Operation) for Hepatocellular Carcinoma in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699816
• Other study ID #: IIC-I01
• Status: Completed
• Phase: Phase 3
• Start date: July 2008
• Est. completion date: November 2012

Study information

• Verified date: August 2015
• Source: GC Cell Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To prove that the efficacy and safety of 'Green Cross CELL* Immuncell-LC group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(PEIT, RFA or operation) for hepatocellular carcinoma in Korea

Description:

Multicenter, randomized, open-labeled phase 3 clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.

• The patient is more than 20 and less than 80 years old

• The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.

• Child-Pugh Score should be less than 6 (refer to the attached file 7)

• No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (PEIT, RFA or operation) in 12 weeks. (based on the agreement date for written consent) The tumor's removal should be perfectly confirmed by pathological or radiological test with the mentioned method in 3) at least 4 weeks later.

• ECOG Performance status (ECOG-PS) is less than 1 or equal to (refer to the exhibit 8)

• Patient's remaining life-time should be expected at least more than 3 months.

• Patient should meet below conditions by blood test, kidney and liver function test

: Re-evaluation is possible during screening

• Leukocyte count is bigger than (3 multiply 109/L)

• Absolute Neutrophil Count (ANC) is bigger than or equal to 1,000/µL

• Hemoglobin is bigger than or equal to 8.5 g/dL

• Thrombocyte count is bigger than (5 multiply 1010/L)

• BUN and serum Creatinine is less than or equal to 1.5 multiply normal upper-limit

• No more disease abdominal extrahepatic transfer is confirmed by abdominal CT/ MRI

Exclusion Criteria:

• Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)

• The carcinoma has been invaded to main portal vein or major branch hepatic vein

• Child-Pugh score is over 6

• Patient has serious problem with pulmonary function by sub- investigator's opinion

• Patient who has disease history of immune deficiency (which can be worse by immunotherapy) or auto-immune disease (ex. arthritis rheumatism, Burger's disease, multiple sclerosis and adolescent-occurred insulin dependent diabetes)

• Diagnosed as an immune deficiency patient

• Patient who has disease history of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate cancer or carcinoma in situ of the uterine cervix

• Patient who had anti-cancer medication before the clinical trial

• Patient who has serious disease in other organs after tumor resection.

• Patient has serious allergic-history by sub- investigator's opinion

• Patient has serious mental disease by sub- investigator's opinion

• Pregnant women, nursing mother or having intention of being pregnant during the clinical test

• Patient who participated in other clinical trial within 4 weeks before this clinical trial

• Patient who is incongruent to this clinical trial by sub- investigator's opinion.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• Immuncell-LC
Activated T lymphocyte

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan si	Gojan1-dong/Danwon-gu
Korea, Republic of	Korea University Guro Hospital	Seoul	Guro 2-Dong, Guro-Gu
Korea, Republic of	Samsung Medical Center	Seoul	Ilwon-dong/Gangnam-gu
Korea, Republic of	Seoul Asan Medical center	Seoul	Pungnab2-dong/Songpa-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Yeongun-dong/Jongro-gu

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. doi: 10.1016/S0140-6736(00)02654-4. Erratum In: Lancet 2000 Nov 11;356(9242):1690. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Free Survival(RFS)	RFS was measured from the date of randomization to the first recurrence or to death from any cause.	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)
Primary	Recurrence Free Survival(RFS) Rate	RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.	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)
Secondary	Overall Survival(OS)	Overall survival was measured from the date of randomization until death from any cause.	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)
Secondary	Cancer-specific Survivals	Cancer-specific survival was measured from the date of randomization until death resulting from HCC.	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)
Secondary	Overall Survival(OS) Rate	Overall survival rate was measured from the date of randomization until death from any cause.	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)
Secondary	Cancer-specific Survival Rate	Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.	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)