Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-05 @ 6:38 PM
Study NCT ID:
NCT02638857
Status:
UNKNOWN
Last Update Posted:
2016-01-01
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
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Dendritic cell infiltration and prognosis of human hepatocellular carcinoma. J Cancer Res Clin Oncol. 2006 May;132(5):293-301. doi: 10.1007/s00432-006-0075-y. Epub 2006 Jan 19.'}, {'pmid': '16113606', 'type': 'BACKGROUND', 'citation': 'Lee WC, Wang HC, Hung CF, Huang PF, Lia CR, Chen MF. Vaccination of advanced hepatocellular carcinoma patients with tumor lysate-pulsed dendritic cells: a clinical trial. J Immunother. 2005 Sep-Oct;28(5):496-504. doi: 10.1097/01.cji.0000171291.72039.e2.'}, {'pmid': '16584401', 'type': 'BACKGROUND', 'citation': 'Gonzalez-Carmona MA, Marten A, Hoffmann P, Schneider C, Sievers E, Schmidt-Wolf IG, Sauerbruch T, Caselmann WH. Patient-derived dendritic cells transduced with an a-fetoprotein-encoding adenovirus and co-cultured with autologous cytokine-induced lymphocytes induce a specific and strong immune response against hepatocellular carcinoma cells. Liver Int. 2006 Apr;26(3):369-79. doi: 10.1111/j.1478-3231.2005.01235.x.'}, {'pmid': '15713517', 'type': 'BACKGROUND', 'citation': 'Yannelli JR, Sturgill J, Foody T, Hirschowitz E. The large scale generation of dendritic cells for the immunization of patients with non-small cell lung cancer (NSCLC). Lung Cancer. 2005 Mar;47(3):337-50. doi: 10.1016/j.lungcan.2004.08.008.'}, {'pmid': '15637694', 'type': 'BACKGROUND', 'citation': 'Chang GC, Lan HC, Juang SH, Wu YC, Lee HC, Hung YM, Yang HY, Whang-Peng J, Liu KJ. A pilot clinical trial of vaccination with dendritic cells pulsed with autologous tumor cells derived from malignant pleural effusion in patients with late-stage lung carcinoma. Cancer. 2005 Feb 15;103(4):763-71. doi: 10.1002/cncr.20843.'}, {'pmid': '16914380', 'type': 'BACKGROUND', 'citation': 'Bellik L, Gerlini G, Parenti A, Ledda F, Pimpinelli N, Neri B, Pantalone D. Role of conventional treatments on circulating and monocyte-derived dendritic cells in colorectal cancer. Clin Immunol. 2006 Oct;121(1):74-80. doi: 10.1016/j.clim.2006.06.011. Epub 2006 Aug 17.'}, {'pmid': '16034561', 'type': 'BACKGROUND', 'citation': 'Babatz J, Rollig C, Lobel B, Folprecht G, Haack M, Gunther H, Kohne CH, Ehninger G, Schmitz M, Bornhauser M. Induction of cellular immune responses against carcinoembryonic antigen in patients with metastatic tumors after vaccination with altered peptide ligand-loaded dendritic cells. Cancer Immunol Immunother. 2006 Mar;55(3):268-76. doi: 10.1007/s00262-005-0021-x. Epub 2005 Jul 21.'}, {'pmid': '16331519', 'type': 'BACKGROUND', 'citation': 'Fay JW, Palucka AK, Paczesny S, Dhodapkar M, Johnston DA, Burkeholder S, Ueno H, Banchereau J. Long-term outcomes in patients with metastatic melanoma vaccinated with melanoma peptide-pulsed CD34(+) progenitor-derived dendritic cells. Cancer Immunol Immunother. 2006 Oct;55(10):1209-18. doi: 10.1007/s00262-005-0106-6. Epub 2005 Dec 6.'}, {'pmid': '16971806', 'type': 'BACKGROUND', 'citation': 'Davis ID, Chen Q, Morris L, Quirk J, Stanley M, Tavarnesi ML, Parente P, Cavicchiolo T, Hopkins W, Jackson H, Dimopoulos N, Tai TY, MacGregor D, Browning J, Svobodova S, Caron D, Maraskovsky E, Old LJ, Chen W, Cebon J. Blood dendritic cells generated with Flt3 ligand and CD40 ligand prime CD8+ T cells efficiently in cancer patients. J Immunother. 2006 Sep-Oct;29(5):499-511. doi: 10.1097/01.cji.0000211299.29632.8c.'}, {'pmid': '16297169', 'type': 'BACKGROUND', 'citation': 'Escobar A, Lopez M, Serrano A, Ramirez M, Perez C, Aguirre A, Gonzalez R, Alfaro J, Larrondo M, Fodor M, Ferrada C, Salazar-Onfray F. Dendritic cell immunizations alone or combined with low doses of interleukin-2 induce specific immune responses in melanoma patients. Clin Exp Immunol. 2005 Dec;142(3):555-68. doi: 10.1111/j.1365-2249.2005.02948.x.'}, {'pmid': '16977630', 'type': 'BACKGROUND', 'citation': 'Thomas-Kaskel AK, Zeiser R, Jochim R, Robbel C, Schultze-Seemann W, Waller CF, Veelken H. Vaccination of advanced prostate cancer patients with PSCA and PSA peptide-loaded dendritic cells induces DTH responses that correlate with superior overall survival. Int J Cancer. 2006 Nov 15;119(10):2428-34. doi: 10.1002/ijc.22097.'}, {'pmid': '16482569', 'type': 'BACKGROUND', 'citation': 'Fuessel S, Meye A, Schmitz M, Zastrow S, Linne C, Richter K, Lobel B, Hakenberg OW, Hoelig K, Rieber EP, Wirth MP. Vaccination of hormone-refractory prostate cancer patients with peptide cocktail-loaded dendritic cells: results of a phase I clinical trial. Prostate. 2006 Jun 1;66(8):811-21. doi: 10.1002/pros.20404.'}, {'pmid': '16612595', 'type': 'BACKGROUND', 'citation': 'Kyte JA, Gaudernack G. Immuno-gene therapy of cancer with tumour-mRNA transfected dendritic cells. Cancer Immunol Immunother. 2006 Nov;55(11):1432-42. doi: 10.1007/s00262-006-0161-7. Epub 2006 Apr 13.'}, {'pmid': '16224272', 'type': 'BACKGROUND', 'citation': 'Wang QJ, Hanada K, Perry-Lalley D, Bettinotti MP, Karpova T, Khong HT, Yang JC. Generating renal cancer-reactive T cells using dendritic cells (DCs) to present autologous tumor. J Immunother. 2005 Nov-Dec;28(6):551-9. doi: 10.1097/01.cji.0000175495.13476.1f.'}, {'pmid': '15918076', 'type': 'BACKGROUND', 'citation': 'Holtl L, Ramoner R, Zelle-Rieser C, Gander H, Putz T, Papesh C, Nussbaumer W, Falkensammer C, Bartsch G, Thurnher M. Allogeneic dendritic cell vaccination against metastatic renal cell carcinoma with or without cyclophosphamide. Cancer Immunol Immunother. 2005 Jul;54(7):663-70. doi: 10.1007/s00262-004-0629-2. Epub 2004 Dec 17.'}, {'pmid': '15944777', 'type': 'BACKGROUND', 'citation': 'Ferrari S, Malugani F, Rovati B, Porta C, Riccardi A, Danova M. Flow cytometric analysis of circulating dendritic cell subsets and intracellular cytokine production in advanced breast cancer patients. Oncol Rep. 2005 Jul;14(1):113-20.'}, {'pmid': '15919376', 'type': 'BACKGROUND', 'citation': 'Bohnenkamp HR, Coleman J, Burchell JM, Taylor-Papadimitriou J, Noll T. Breast carcinoma cell lysate-pulsed dendritic cells cross-prime MUC1-specific CD8+ T cells identified by peptide-MHC-class-I tetramers. Cell Immunol. 2004 Sep-Oct;231(1-2):112-25. doi: 10.1016/j.cellimm.2004.12.007. Epub 2005 Feb 8.'}, {'pmid': '15625541', 'type': 'BACKGROUND', 'citation': 'Chen W, Chan AS, Dawson AJ, Liang X, Blazar BR, Miller JS. FLT3 ligand administration after hematopoietic cell transplantation increases circulating dendritic cell precursors that can be activated by CpG oligodeoxynucleotides to enhance T-cell and natural killer cell function. Biol Blood Marrow Transplant. 2005 Jan;11(1):23-34. doi: 10.1016/j.bbmt.2004.08.004.'}, {'pmid': '11135227', 'type': 'BACKGROUND', 'citation': 'Triozzi PL, Khurram R, Aldrich WA, Walker MJ, Kim JA, Jaynes S. Intratumoral injection of dendritic cells derived in vitro in patients with metastatic cancer. Cancer. 2000 Dec 15;89(12):2646-54. doi: 10.1002/1097-0142(20001215)89:123.0.co;2-a.'}, {'pmid': '11426654', 'type': 'BACKGROUND', 'citation': 'Nestle FO. Dendritic cell vaccination for cancer therapy. Oncogene. 2000 Dec 27;19(56):6673-9. doi: 10.1038/sj.onc.1204095.'}, {'pmid': '10760827', 'type': 'BACKGROUND', 'citation': 'Mackensen A, Herbst B, Chen JL, Kohler G, Noppen C, Herr W, Spagnoli GC, Cerundolo V, Lindemann A. Phase I study in melanoma patients of a vaccine with peptide-pulsed dendritic cells generated in vitro from CD34(+) hematopoietic progenitor cells. Int J Cancer. 2000 May 1;86(3):385-92. doi: 10.1002/(sici)1097-0215(20000501)86:33.0.co;2-t.'}, {'pmid': '15124022', 'type': 'BACKGROUND', 'citation': 'Iinuma T, Homma S, Noda T, Kufe D, Ohno T, Toda G. Prevention of gastrointestinal tumors based on adenomatous polyposis coli gene mutation by dendritic cell vaccine. J Clin Invest. 2004 May;113(9):1307-17. doi: 10.1172/JCI17323.'}, {'pmid': '12631598', 'type': 'BACKGROUND', 'citation': 'Butterfield LH, Ribas A, Dissette VB, Amarnani SN, Vu HT, Oseguera D, Wang HJ, Elashoff RM, McBride WH, Mukherji B, Cochran AJ, Glaspy JA, Economou JS. Determinant spreading associated with clinical response in dendritic cell-based immunotherapy for malignant melanoma. Clin Cancer Res. 2003 Mar;9(3):998-1008.'}, {'pmid': '12021308', 'type': 'BACKGROUND', 'citation': 'Schuler-Thurner B, Schultz ES, Berger TG, Weinlich G, Ebner S, Woerl P, Bender A, Feuerstein B, Fritsch PO, Romani N, Schuler G. Rapid induction of tumor-specific type 1 T helper cells in metastatic melanoma patients by vaccination with mature, cryopreserved, peptide-loaded monocyte-derived dendritic cells. J Exp Med. 2002 May 20;195(10):1279-88. doi: 10.1084/jem.20012100.'}, {'pmid': '12682787', 'type': 'BACKGROUND', 'citation': "O'Rourke MG, Johnson M, Lanagan C, See J, Yang J, Bell JR, Slater GJ, Kerr BM, Crowe B, Purdie DM, Elliott SL, Ellem KA, Schmidt CW. Durable complete clinical responses in a phase I/II trial using an autologous melanoma cell/dendritic cell vaccine. Cancer Immunol Immunother. 2003 Jun;52(6):387-95. doi: 10.1007/s00262-003-0375-x. Epub 2003 Apr 8."}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nThe purpose of this study is to evaluate the safety and efficacy of dendritic cell-precision multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma.\n\nMethods： This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial chemoembolization group and dendritic cell-precision multiple antigen T cells combined with transcatheter arterial chemoembolization group. Treatments will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.', 'detailedDescription': 'A total of 60 patients may be enrolled over a period of 1-2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18\\~65 years old, male or female\n2. Signed informed consent\n3. Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out.\n4. The recurrence of HCC was found after the operation without distant metastasis.\n5. The Eastern Cooperative Oncology Group (ECOG) score ≤2\n6. Child-Pugh score of liver function ≤ 9\n7. Routine blood meets the requirements.\n\nExclusion Criteria:\n\n1. Expected Overall survival \\< 3 months\n2. The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus\n3. Liver function is Childs Pugh C\n4. Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney\n5. Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.\n6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.'}, 'identificationModule': {'nctId': 'NCT02638857', 'briefTitle': 'Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Second Military Medical University'}, 'officialTitle': 'A Controlled Clinic Trial of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Combination With Transcatheter Arterial Chemoembolization in Treating Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'EHBHKY2015-02-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Transcatheter Arterial Chemoembolization', 'description': 'Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.', 'interventionNames': ['Procedure: TACE', 'Drug: lipiodol', 'Drug: Mitomycin (MMC)', 'Drug: Epirubicin(EADM)']}, {'type': 'EXPERIMENTAL', 'label': 'DC-PMAT cells', 'description': 'After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.', 'interventionNames': ['Procedure: TACE', 'Biological: Dendritic Cell', 'Drug: lipiodol', 'Drug: Mitomycin (MMC)', 'Drug: Epirubicin(EADM)', 'Biological: Precision Multiple Antigen T Cell']}], 'interventions': [{'name': 'TACE', 'type': 'PROCEDURE', 'description': 'lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.', 'armGroupLabels': ['DC-PMAT cells', 'Transcatheter Arterial Chemoembolization']}, {'name': 'Dendritic Cell', 'type': 'BIOLOGICAL', 'otherNames': ['DC'], 'description': 'DC suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62.', 'armGroupLabels': ['DC-PMAT cells']}, {'name': 'lipiodol', 'type': 'DRUG', 'description': 'lipiodol 10-20ml,hepatic arterial infusion', 'armGroupLabels': ['DC-PMAT cells', 'Transcatheter Arterial Chemoembolization']}, {'name': 'Mitomycin (MMC)', 'type': 'DRUG', 'description': 'MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.', 'armGroupLabels': ['DC-PMAT cells', 'Transcatheter Arterial Chemoembolization']}, {'name': 'Epirubicin(EADM)', 'type': 'DRUG', 'description': 'EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.', 'armGroupLabels': ['DC-PMAT cells', 'Transcatheter Arterial Chemoembolization']}, {'name': 'Precision Multiple Antigen T Cell', 'type': 'BIOLOGICAL', 'otherNames': ['PMAT cell'], 'description': 'PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.', 'armGroupLabels': ['DC-PMAT cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huajun Jin, phd', 'role': 'CONTACT', 'email': 'hj-jin@hotmail.com', 'phone': '+86-21-81875372'}, {'name': 'Feng Shen, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qijun Qian, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zengqiang Qu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qian Zhang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Huajun Jin, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yao Huang, PHD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yan Sun, PHD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fuping Zhou, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Eastern Hepatobiliary Surgery Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qijun Qian, PHD', 'role': 'CONTACT', 'email': 'qianqj@sino-gene.cn', 'phone': '+86-21-65580677'}, {'name': 'Huajun Jin, PHD', 'role': 'CONTACT', 'email': 'hj-jin@Hotmail.com', 'phone': '+86-21-81875372'}], 'overallOfficials': [{'name': 'Feng Shen, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}