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

NCT ID: NCT00699816

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunotherapy Group

Adjuvant adoptive immune therapy using a CIK cell agent(Immuncell-LC) 16 times(4 treatments at a frequency of once per week, followed by 4 treatments every 2 weeks, then 4 treatments every 4 weeks, and finally 4 treatments every 8 weeks.

Group Type: EXPERIMENTAL

Immuncell-LC

Intervention Type: BIOLOGICAL

Activated T lymphocyte

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Immuncell-LC

Activated T lymphocyte

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GC Cell Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jung Hwan Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Korea University Ansan Hospital

Ansan-si, Gojan1-dong/Danwon-gu, South Korea

Korea University Guro Hospital

Seoul, Guro 2-Dong, Guro-Gu, South Korea

Samsung Medical Center

Seoul, Ilwon-dong/Gangnam-gu, South Korea

Seoul Asan Medical center

Seoul, Pungnab2-dong/Songpa-gu, South Korea

Seoul National University Hospital

Seoul, Yeongun-dong/Jongro-gu, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 11022927 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25747273 (View on PubMed)

Other Identifiers

IIC-I01

Identifier Type: -

Identifier Source: org_study_id