NCT01897610

Brief Summary

"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2013

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2017

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

3.6 years

First QC Date

June 25, 2013

Last Update Submit

June 22, 2023

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Immuncell-LC, advanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • To assess progression-free survival (PFS)

    CT, PET-CT, MRI

    up to 2 years

Secondary Outcomes (4)

  • To assess the overall survival (OS)

    up to 2 years

  • To evaluate the Disease control rate

    up to 2 years

  • To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date

    up to 2 years

  • Number of participants with adverse events

    up to 2 years

Study Arms (2)

control group

NO INTERVENTION

The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.

Immuncell-LC group

EXPERIMENTAL

The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after baseline by administering Nexavar chemotherapy same as control group with Immuncell-LC (10 times).

Drug: Immuncell-LC

Interventions

Immuncell-LCDRUG

intravenous dripping of 200ml(10\^9\~2x10\^10 lymphocytes/60kg adult) for 1 hour

Also known as: Activated T lymphocyte
Immuncell-LC group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have consented to the study by providing signature of self, guardian or legal representative
  • The patient is more than 20 and less than 80 years old
  • The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV
  • Child-Pugh Score should be A
  • ECOG Performance Status (ECOG-PS) is less than 2 or equal to
  • Patients who receiving or ready for Nexavar treatment
  • Patients who satisfy the following conditions of the blood test and kidney function test
  • Absolute granulocyte count is bigger than 1,000/µL
  • Hemoglobin is bigger than 8.5 g/dL
  • Platelet count is bigger than 5x10\^10/L
  • Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit

You may not qualify if:

  • Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
  • Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer.
  • Patients who had anti-cancer medication before the study with the exception of Nexavar
  • Patients who has serious dysfunction in other organs by sub-investigator's opinion
  • Patients has serious allergic-history by sub-investigator's opinion
  • Patients has serious mental disease sub-investigator's opinion
  • Pregnant women, nursing mother of having intention of being pregnant during the study
  • Patients who participated in other clinical trial within 4 weeks before this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Inha University Hospital

Incheon, 400-711, South Korea

Location

Yonsei University Health System

Seoul, 120-752, South Korea

Location

Korea University Anam Hospital

Seoul, 136-750, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 137-701, South Korea

Location

Related Publications (8)

  • Di Maio M, De Maio E, Perrone F, Pignata S, Daniele B. Hepatocellular carcinoma: systemic treatments. J Clin Gastroenterol. 2002 Nov-Dec;35(5 Suppl 2):S109-14. doi: 10.1097/00004836-200211002-00007.

    PMID: 12394214BACKGROUND

  • Ganne-Carrie N, Trinchet JC. Systemic treatment of hepatocellular carcinoma. Eur J Gastroenterol Hepatol. 2004 Mar;16(3):275-81. doi: 10.1097/00042737-200403000-00005.

    PMID: 15195890BACKGROUND

  • Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.

    PMID: 19095497BACKGROUND

  • Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

    PMID: 18650514BACKGROUND

  • Furuse J, Ishii H, Nakachi K, Suzuki E, Shimizu S, Nakajima K. Phase I study of sorafenib in Japanese patients with hepatocellular carcinoma. Cancer Sci. 2008 Jan;99(1):159-65. doi: 10.1111/j.1349-7006.2007.00648.x. Epub 2007 Oct 22.

    PMID: 17953709BACKGROUND

  • Shim JH, Park JW, Choi JI, Park BJ, Kim CM. Practical efficacy of sorafenib monotherapy for advanced hepatocellular carcinoma patients in a Hepatitis B virus-endemic area. J Cancer Res Clin Oncol. 2009 Apr;135(4):617-25. doi: 10.1007/s00432-008-0496-x. Epub 2008 Oct 10.

    PMID: 18846384BACKGROUND

  • 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: 11022927BACKGROUND

  • Kim HM, Lim J, Yoon YD, Ahn JM, Kang JS, Lee K, Park SK, Jeong YJ, Kim JM, Han G, Yang KH, Kim YJ, Kim Y, Han SB. Anti-tumor activity of ex vivo expanded cytokine-induced killer cells against human hepatocellular carcinoma. Int Immunopharmacol. 2007 Dec 15;7(13):1793-801. doi: 10.1016/j.intimp.2007.08.007. Epub 2007 Aug 31.

    PMID: 17996690BACKGROUND

Study Officials

  • Soon Ho Um, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 12, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 4, 2017

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

KR(4)