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"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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immuncell-LC | Drug | intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess progression-free survival (PFS) | CT, PET-CT, MRI | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the overall survival (OS) | up to 2 years | |
| To evaluate the Disease control rate | to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soon Ho Um, MD, PhD | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | 400-711 | South Korea | |||
| Yonsei University Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12394214 | Background | 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. | |
| 15195890 | Background | 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. |
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| up to 2 years |
| 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 |
| Number of participants with adverse events | up to 2 years |
| Seoul |
| 120-752 |
| South Korea |
| Korea University Anam Hospital | Seoul | 136-750 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 137-701 | South Korea |
| 19095497 | Background | 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. |
| 18650514 | Background | 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. |
| 17953709 | Background | 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. |
| 18846384 | Background | 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. |
| 11022927 | Background | 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. |
| 17996690 | Background | 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. |