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

NCT00699816 | Completed Phase 3 Results

• 1 other identifier: IIC-I01
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 5

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Overall Survival(OS)

  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)

• Cancer-specific Survivals

  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)

• Overall Survival(OS) Rate

  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)

• Cancer-specific Survival Rate

  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)

Study Arms (2)

Immunotherapy Group

EXPERIMENTAL

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.

Biological: Immuncell-LC

Control Group

NO INTERVENTION

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

Interventions

Immuncell-LC BIOLOGICAL

Activated T lymphocyte

Immunotherapy Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (5)

Korea University Ansan Hospital

Ansan-si, Gojan1-dong/Danwon-gu, 425-707, South Korea

Location

Korea University Guro Hospital

Seoul, Guro 2-Dong, Guro-Gu, 152-703, South Korea

Location

Samsung Medical Center

Seoul, Ilwon-dong/Gangnam-gu, 135-710, South Korea

Location

Seoul Asan Medical center

Seoul, Pungnab2-dong/Songpa-gu, 138-736, South Korea

Location

Seoul National University Hospital

Seoul, Yeongun-dong/Jongro-gu, 110-744, South Korea

Location

Related Publications (2)

• 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.

  PMID: 11022927 BACKGROUND

• 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.

  PMID: 25747273 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Jung-Hwan Yoon, MD, PhD
• Organization: Seoul National University College of Medicine

yoonjh@snu.ac.kr

+82-2-2072-2228

Study Officials

• Jung Hwan Yoon, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 18, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 11, 2023
• Results First Posted: September 24, 2015

Record last verified: 2015-08

Locations

KR (5)