Clinical trial NCT00699816: Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 230
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: Multicenter, randomized, open-labeled phase 3 clinical trial.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence Free Survival(RFS)
timeFrame: 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)
measure: Recurrence Free Survival(RFS) Rate
timeFrame: 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 outcomes:
measure: Overall Survival(OS)
timeFrame: 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)
measure: Cancer-specific Survivals
timeFrame: 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)
measure: Overall Survival(OS) Rate
timeFrame: 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)
measure: Cancer-specific Survival Rate
timeFrame: 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)
Other outcomes:
Locations:
city: Ansan si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gojan1-dong/Danwon-gu
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro 2-Dong, Guro-Gu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Ilwon-dong/Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical center
state: Pungnab2-dong/Songpa-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Yeongun-dong/Jongro-gu
Study officials:
affiliation: Seoul National University Hospital
name: Jung Hwan Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.