Back to resultsImmunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma
Primary Purpose
Recurrence Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TACE
Dendritic Cell
lipiodol
Mitomycin (MMC)
Epirubicin(EADM)
Precision Multiple Antigen T Cell
Sponsored by
About this trial
This is an interventional treatment trial for Recurrence Hepatocellular Carcinoma focused on measuring Recurrence Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Dendritic Cell -Precision Multiple Antigen T Cells, Transcatheter Arterial Chemoembolization
Eligibility Criteria
Inclusion Criteria:
- Age 18~65 years old, male or female
- Signed informed consent
- Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out.
- The recurrence of HCC was found after the operation without distant metastasis.
- The Eastern Cooperative Oncology Group (ECOG) score ≤2
- Child-Pugh score of liver function ≤ 9
- Routine blood meets the requirements.
Exclusion Criteria:
- Expected Overall survival < 3 months
- The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus
- Liver function is Childs Pugh C
- Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney
- Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Sites / Locations
- Eastern Hepatobiliary Surgery HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Transcatheter Arterial Chemoembolization
DC-PMAT cells
Arm Description
Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Progress-free survival
Quality of life
Quality of life core questionnaire will be used.
Full Information
NCT ID
NCT02638857
First Posted
December 9, 2015
Last Updated
December 30, 2015
Sponsor
Second Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02638857
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Military Medical University
4. Oversight
5. Study Description
Brief Summary
Objectives:
The 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.
Methods： 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.
Detailed Description
A total of 60 patients may be enrolled over a period of 1-2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma
Keywords
Recurrence Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Dendritic Cell -Precision Multiple Antigen T Cells, Transcatheter Arterial Chemoembolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcatheter Arterial Chemoembolization
Arm Type
Sham Comparator
Arm Description
Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
Arm Title
DC-PMAT cells
Arm Type
Experimental
Arm Description
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention 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.
Intervention Type
Biological
Intervention Name(s)
Dendritic Cell
Other Intervention Name(s)
DC
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
lipiodol
Intervention Description
lipiodol 10-20ml,hepatic arterial infusion
Intervention Type
Drug
Intervention Name(s)
Mitomycin (MMC)
Intervention Description
MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.
Intervention Type
Drug
Intervention Name(s)
Epirubicin(EADM)
Intervention Description
EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.
Intervention Type
Biological
Intervention Name(s)
Precision Multiple Antigen T Cell
Other Intervention Name(s)
PMAT cell
Intervention 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.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progress-free survival
Time Frame
2 years
Title
Quality of life
Description
Quality of life core questionnaire will be used.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18~65 years old, male or female
Signed informed consent
Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out.
The recurrence of HCC was found after the operation without distant metastasis.
The Eastern Cooperative Oncology Group (ECOG) score ≤2
Child-Pugh score of liver function ≤ 9
Routine blood meets the requirements.
Exclusion Criteria:
Expected Overall survival < 3 months
The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus
Liver function is Childs Pugh C
Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney
Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qijun Qian, PHD
Phone
+86-21-65580677
Email
qianqj@sino-gene.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Shen, PHD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huajun Jin, phd
Phone
+86-21-81875372
Email
hj-jin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Feng Shen, PHD
First Name & Middle Initial & Last Name & Degree
Qijun Qian, PHD
First Name & Middle Initial & Last Name & Degree
Zengqiang Qu, PHD
First Name & Middle Initial & Last Name & Degree
Qian Zhang, PHD
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
First Name & Middle Initial & Last Name & Degree
Yao Huang, PHD
First Name & Middle Initial & Last Name & Degree
Yan Sun, PHD
First Name & Middle Initial & Last Name & Degree
Fuping Zhou, PHD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16421755
Citation
Cai XY, Gao Q, Qiu SJ, Ye SL, Wu ZQ, Fan J, Tang ZY. 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.
Results Reference
background
PubMed Identifier
16113606
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.
Results Reference
background
PubMed Identifier
16584401
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.
Results Reference
background
PubMed Identifier
15713517
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.
Results Reference
background
PubMed Identifier
15637694
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.
Results Reference
background
PubMed Identifier
16914380
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.
Results Reference
background
PubMed Identifier
16034561
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.
Results Reference
background
PubMed Identifier
16331519
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.
Results Reference
background
PubMed Identifier
16971806
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.
Results Reference
background
PubMed Identifier
16297169
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.
Results Reference
background
PubMed Identifier
16977630
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.
Results Reference
background
PubMed Identifier
16482569
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.
Results Reference
background
PubMed Identifier
16612595
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.
Results Reference
background
PubMed Identifier
16224272
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.
Results Reference
background
PubMed Identifier
15918076
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.
Results Reference
background
PubMed Identifier
15944777
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.
Results Reference
background
PubMed Identifier
15919376
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.
Results Reference
background
PubMed Identifier
15625541
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.
Results Reference
background
PubMed Identifier
11135227
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.
Results Reference
background
PubMed Identifier
11426654
Citation
Nestle FO. Dendritic cell vaccination for cancer therapy. Oncogene. 2000 Dec 27;19(56):6673-9. doi: 10.1038/sj.onc.1204095. Erratum In: Oncogene 2001 Oct 18;20(47):6970.
Results Reference
background
PubMed Identifier
10760827
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.
Results Reference
background
PubMed Identifier
15124022
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.
Results Reference
background
PubMed Identifier
12631598
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.
Results Reference
background
PubMed Identifier
12021308
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. Erratum In: J Exp Med. 2003 Feb 3;197(3):395.
Results Reference
background
PubMed Identifier
12682787
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.
Results Reference
background
Learn more about this trial
Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma
We'll reach out to this number within 24 hrs