Clinical trial · Interventional
Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC
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
NCT01897610CI-TRIAL-00067518completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
"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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immuncell-LC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group
- description
- The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.
- type
- EXPERIMENTAL
- label
- Immuncell-LC group
- description
- 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).
- interventionNames
- Drug: Immuncell-LC
Primary outcomes (1)
- measure
- To assess progression-free survival (PFS)
- timeFrame
- up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDDi 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 12394214
- BACKGROUNDGanne-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 15195890
- BACKGROUNDCheng 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 19095497
- BACKGROUNDLlovet 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 18650514
- BACKGROUNDFuruse 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 17953709
- BACKGROUNDShim 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 18846384