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


Phase 3
20 Years
80 Years
Not Enrolling
Both
Hepatocellular Carcinoma

Thank you

Trial Information

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


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 Ccount is bigger than (3 multiply 109/L)

- Absolute Neutrophil Count (ANC) is bigger than or equal to 1,000/┬ÁL

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiological test should be operated by dynamic CT (using 64 cut), dynamic MRI or by angiography.

Outcome Time Frame:

Every 3months from the baseline

Safety Issue:

Yes

Principal Investigator

Jung Hwan Yoon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

IIC-I01

NCT ID:

NCT00699816

Start Date:

July 2008

Completion Date:

November 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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