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Status unknownNCT02632188Updated Jan 1, 2016

Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma

A Phase 1/2 interventional study of Postoperative routine treatment and DC-PMAT treatment in Liver Cancer, sponsored by Second Military Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-01.

Sponsored by Second Military Medical University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

Objectives:

The purpose of this study is to evaluate the safety and efficacy of radical surgery combined with dendritic cell-precision multiple antigen T cells in reducing the recurrence and metastasis of liver cancer

Methods:

This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly divided into postoperative routine therapy group and dendritic cell-precision multiple antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision multiple antigen T cells treatments will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

Read the detailed description

A total of 60 patients may be enrolled over a period of 1-2 years.

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Conditions studied

  • Liver Cancer

Keywords

  • Recurrence
  • Metastasis
  • liver cancer
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In context

Carcinoma, Hepatocellular

3,180 studies on the registry are indexed under Carcinoma, Hepatocellular; 953 are open to participants now.

This study's planned enrollment of 60 is close to the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Second Military Medical University is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18\~65 years old, male or female
  2. Signed informed consent
  3. Diagnosis of hepatocellular carcinoma (HCC), radical surgery was performed
  4. The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out
  5. The Eastern Cooperative Oncology Group (ECOG) score ≤2
  6. Child-Pugh score of liver function ≤ 9
  7. Routine blood meets the requirements

Exclusion criteria

Exclusion Criteria:

  1. Expected Overall survival \< 3 months
  2. Radical surgery was not performed or recurrence was found after operation
  3. Liver function is Childs Pugh C
  4. Had received other immunotherapy
  5. Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
  6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Postoperative routine treatment

    Postoperative routine treatment according to the hospitals local routines

    Procedure: Postoperative routine treatment

  • Experimental
    DC-PMAT treatment

    On the basis of postoperative routine treatment, patients will receive 3 cycles of dendritic cell-precision multiple antigen T (DC-PMAT) cells treatment.

    Procedure: Postoperative routine treatment · Biological: DC-PMAT treatment

Interventions

  • ProcedurePostoperative routine treatment

    Postoperative routine treatment according to the hospitals local routines

  • BiologicalDC-PMAT treatment

    Postoperative routine treatment according to the hospitals local routines; DC cell 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. 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.

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What researchers measure

Primary outcomes

  1. Progress-free survival

    Time frame: 2 years

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

  2. Quality of life

    Quality of life core questionnaire will be used.

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Eastern Hepatobiliary Surgery Hospital
    Shanghai, 200438, China
    • Huajun Jin, PHD · Contact · hj-jin@hotmail.com · +86-21-81875372
    • Weiping Zhou, PHD,MD · Principal investigator
    • Qijun Qian, PHD · Principal investigator
    • Huajun Jin, PHD · Principal investigator
    • Qian Zhang, PHD,MD · Principal investigator
    • Hui Liu, MD · Principal investigator
    • Siyuan Fu, MD · Sub investigator
    • Yan Sun, MD · Sub investigator
    • Fuping Zhou, MD · Sub investigator
    • Yao Huang, MD · Sub investigator
    Recruiting
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References and documents

Publications

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  • 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. PubMed 16113606 ↗
  • 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. PubMed 16584401 ↗
  • 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. PubMed 15713517 ↗
  • 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. PubMed 15637694 ↗
  • 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. PubMed 16914380 ↗
  • 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. PubMed 16034561 ↗
  • 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. PubMed 16331519 ↗
  • 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. PubMed 16971806 ↗
  • 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. PubMed 16297169 ↗
  • 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. PubMed 16977630 ↗
  • 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. PubMed 16482569 ↗
  • 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. PubMed 16612595 ↗
  • 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. PubMed 16224272 ↗
  • 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. PubMed 15918076 ↗
  • 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. PubMed 15944777 ↗
  • 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. PubMed 15919376 ↗
  • 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. PubMed 15625541 ↗
  • 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. PubMed 11135227 ↗
  • 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. PubMed 11426654 ↗
  • 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. PubMed 10760827 ↗
  • 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. PubMed 15124022 ↗
  • 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. PubMed 12631598 ↗
  • 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. PubMed 12021308 ↗
  • 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. PubMed 12682787 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02632188
Lead sponsor
Second Military Medical University
Responsible party
Sponsor
First posted
Dec 16, 2015
Start date
Sep 2015
Primary completion
Mar 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Jan 1, 2016

Study contacts

Qijun Qian, PHD
Contact
qianqj@sino-gene.cn
+86-21-65580677
Huajun Jin, PHD
Contact
hj-jin@Hotmail.com
+86-21-81875372
Weiping Zhou, PHD,MD
study chair · Eastern Hepatobiliary Surgery Hospital
View the source record on ClinicalTrials.gov ↗

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