Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897610
• Other study ID #: ILC-IIT-04
• Status: Completed
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: July 4, 2017

Study information

• Verified date: June 2023
• Source: GC Cell Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group

• secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 4, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Immuncell-LC
intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet 2000 Nov 11;356(9242):1690. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess progression-free survival (PFS)	CT, PET-CT, MRI	up to 2 years
Secondary	To assess the overall survival (OS)		up to 2 years
Secondary	To evaluate the Disease control rate	to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST	up to 2 years
Secondary	To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date	analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC	up to 2 years
Secondary	Number of participants with adverse events		up to 2 years