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

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: Immuncell-LC

• Registration Number: NCT00699816
• Lead Sponsor: GC Cell Corporation

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.

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2008-07
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2015-06-18
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-23
• Results First Posted: 2015-09-24
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunotherapy Group	Immuncell-LC	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.

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival(RFS)	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)	RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Recurrence Free Survival(RFS) 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)	RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.

Secondary Outcome Measures

Name	Time	Method
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)	Cancer-specific survival was measured from the date of randomization until death resulting from HCC.
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)	Overall survival was measured from the date of randomization until death from any cause.
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)	Overall survival rate was measured from the date of randomization until death from any cause.
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)	Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.

Trial Locations

Locations (5)

Korea University Guro Hospital; 🇰🇷 Seoul, Guro 2-Dong, Guro-Gu, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan si, Gojan1-dong/Danwon-gu, Korea, Republic of

Seoul Asan Medical center; 🇰🇷 Seoul, Pungnab2-dong/Songpa-gu, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Ilwon-dong/Gangnam-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Yeongun-dong/Jongro-gu, Korea, Republic of