Hasumi*, Y. Kusaka*, Y. Aoki*, R. Watanabe*, D.L. Mann**

*Hasumi International Research Foundation

**University of Maryland School of Medicine


Human initiated therapeutic vaccine (HITV) therapy is consisting of three protocols that could be reaching to complete response (CR) after combination therapies of immature dendritic cells (iDCs), intensity modulated radiation therapy (IMRT) and chemotherapy indicated for stage IV and recurrent cancer patients with various diagnosis. Prior to starting treatment, PET-CT examined to identify number and size of tumors. The protocol A consisted with intra-tumoral injection of iDCs, infusion of activated T cells (AT) and combined with IMRT and then followed by isolation of cytotoxic T cells (CTLs) from PBMC and expanded by IL-2, using for intra-tumoral injection against incomplete or new lesions that are identified by evaluation PET-CT. Protocol B is conjunction of first line chemotherapy and iDCs to use for systemic regulation after protocol A induction. After completion of CR by protocol A and/or protocol B, Protocol C will be used for prevention of recurrent to maintain CR over three years. Periodical follow up by iDCs and AT administration and by PET-CT examination is necessary whether new lesions might be found. The interval of iDCs and AT administration start monthly finally up to every 6 months that is depending on the results of PET-CT in every 3~6 months. During maintenance protocol C if new lesions will be found iDCs alone or PD-L1 will be co-injected intra-tumorally. Patients were grouped for outcome analysis based on number and size of tumors and clinical status at treatment initiation. In case of recurrent patients with number of tumors 5 or less and largest size of tumor 3 cm or less, and for newly diagnosed stage IV patients with 10 tumors or less and 5 cm or less were good indication for HITV therapy founded by our cohort study. According to above criteria of indication, we analyzed 97 new patients who started HITV treatment from 2014/01/01 to 2016/04/25 and efficacy was finally evaluated after 3 years. 72 patients who received protocol A or B or A+B were out of criteria with large and numerous lesions resulted in CR 0 (0%), PR 5 (8.33%), SD 2 (3.33%), PD 6 (10.6%), TOD 47 (78.3%), DO 12. On the other hand, in criteria patients provided into recurrent and stage IV, and 15 recurrent patients who received Protocol A+C were already chemo-resistance showed CR 8 (72.8%), PR 0 (0%), SD 1 (9.1%), PD 1 (9.1%), TOD 1 (9.1%), DO 4 and 9 stage IV patients who received protocol A+B+C were not starting any treatment showed CR 7 (77.8%), PR 0 (0%), SD 1 (11.1%), PD 1 (11.1%), TOD 0 (0%), DO 0. These data strongly suggested if HITV combined with conventional therapies we should consider HITV indication that includes number and size of tumors, clinical & pathological diagnosis and history of treatment.


Kenichiro Hasumi, MD

Founder of Hasumi International Research Foundation Bulgaria, Tokyo, Japan,

Doctor Honoris Causa of Medical University-Pleven, Bulgaria


Education & Professional Training:

1982 - 1988: Department of Immunology, Electro-chemical & Cancer Institute Shukokai Incorporated, Japan

1978 - 1982: Department of Surgery, the Institute of Medical Science University of Tokyo, Japan Department of Anesthesiology, Showa University, Japan Department of Surgery, Musashino Red Cross Hospital, Japan

1972 - 1978: Saitama Medical School (Obtained Medical Doctor's License), Japan

1969 - 1972: School of Chemistry, Toho University, Japan



  • Gastroenterological Surgery Surgery
  • Immunology
  • Oncology
  • Terminal & Palliative Care



2017 -

: Director, WISH Foundation, Switzerland

2014 -

: Physician, K-101 Clinic, Shukokai Incorporated, Japan

2011 -

: Physician, BSL-48, Shukokai Incorporated, Japan

2006 -

: Physician, Founder/Chairman, ICVS, Tokyo Clinic & Research Institute, Japan

2005 -

: Founder, Hasumi International Research Foundation - Bulgaria

1999 -

: Founder, World Immuno-Society for Health (WISH), Switzerland

1999 -

: Director Board of Trustees, Noguchi Medical Research Institute, USA

1999 -

: Founder/Chairman, Hasumi International Research Foundation, USA

1998 -

: Honorable President of Jilin Cancer Center, China

1997 -

: Visiting Professor, Thomas Jefferson University, USA

1994 -

: Visiting Professor, Chaoshung Chinese Medical University Chaoshung, China

1988 -

: Chairman/CEO, Shukokai Incorporated, Japan


1) Hijirigaoka Hospital


2) Electro-chemical & Cancer Institute


3) Shukokai Clinic


Awards & Achievements:

2015: Established "K. Hasumi Professor Chair" at Thomas Jefferson University, Jefferson Medical College, USA

2014: Received Doctor Honoris Causa of Medical University-Pleven, Bulgaria

2010: Granted the badge of honor "For special merit to the Bulgarian Academy of Sciences" from the Executive Council of the Bulgarian Academy of Sciences, Bulgaria

2007: Granted the Spirit of Change Award from The Kimmel Cancer Center, Thomas Jefferson University, USA

1996: Granted the Medal of "National Order of the Southern Cross" from Brazilian Government, Brazil Granted Camara Municipal De Sao Paulo, Brazil




"The 14th International Medical Scientific Conference for Students and Young Doctors, held in Medical University-Pleven, Bulgaria


"The 13th International Medical Scientific Conference for Students and Young

 Doctors, held in Medical University-Pleven, Bulgaria


"The 8th Meeting with International Participation – Together in Cancer Control: Immunology, Viruses, Natural Remedies", Medical University-Pleven, Bulgaria


"The 7th Meeting International Participation 2013 - “Vaccines, Viruses and Contemporary Cancer Treatment”", Medical University-Pleven, Bulgaria

"Cell-Based Anti-Cancer Treatment-Part3" College Of Pathologists Academy Of

Medicine Of Malaysia

"Cell Based And Advanced Technology Anti-Cancer Treatment" Murni Teguh

Memorial Hospital, Malaysia


"Future Cancer Treatment - New concept and modality" Murni Teguh Memorial

Hospital, Medan, Indonesia

"The 6th Meeting International participation in Pleven - Onco-Immunology: new horizons" Medical University-Pleven, Bulgaria

"Intra-tumoral injection of dendritic cells induces specific killer T-cell activity" at The 7th International Cancer Vaccine Symposium, Florence, Italy


"College of Pathologists Academy of Medicine of Malaysia" Kuala Lumpur, Malaysia

"8th National Congress of Oncology" Sofia, Bulgaria

"Gynecologic cancer diagnosis and treatment Awakening Symposium 2011", China Medial University Hospital, Taiwan


"IAMP Scientific Meeting & 3rd General Assembly 2010", Kuala Lumpur, Malaysia

"Onco-Progress - Onco-Vaccine 2010" Bulgarian Academy of Sciences


"International Symposium of Antitumoral Immunotherapy and aniti-cancer Vaccinations", The college of Bouzareah, Algeria

"Open Doors for Bio-Immune Therapy of Cancer", The Bulgarian Academy of Sciences, Bulgaria


Matalam University, Indonesia

"The Elderly People - Life with a Future", the Ministry of Labour and Social Policy of the Republic of Bulgaria


"Advanced Cancer Therapy, DC Intratumoral Injection", National University of Singapore

"Advanced Cancer Therapy, DC Intratumoral Injection", Taiwan University

"Immune Support of Health through Nature and Science", Hissarya, Bulgaria


"Advanced Cancer Therapy, DC Intratumoral Injection", Taipei Medical School

"Advanced Cancer Therapy, DC Intratumoral Injection", The Bulgarian Academy of Sciences


The 13th International Conference, AIDS, Cancer and Related Problems",

St. Petersberg, Russia


"The 20th Years' Anniversary Academic Congress of Traditional Chinese Medicine", School of Post Baccalaureate Chinese Medicine, China Medical University


"La Historia y Nuevas Direcciones en Vacunas en Cancer", Sociedad Medica del Instituto Nacional de Cancerologia, Mexico

"The 18th UICC International Cancer Congress", Oslo, Norway

"The 10th International Conference, AIDS, Cancer and Related Problems", St. Petersberg, Russia


"The 15th International Conference on Human Functioning", Wichita, Kansas,



"Cancer Vaccine Therapy", Jilin Cancer Center, China


"The 5th International Conference, AIDS, Cancer and Related Problems", St. Petersberg, Russia

"Cancer Immunotherapy", Taipei Medical College, Taiwan


"Cancer and Immunology", Sao Paulo, Brazil


"Cancer Immunology Conference", Tehran University, Iran


"Cancer & Immunology", Chaoshung Chinese Medical College, China

"World Congress on Cancer", Sydney, Australia


"Vaccine Contro Il Cancro? Si, Grazie!", Roma, Italy


"Cancer and Virus, Improvement of Human Functioning", Wichita, Kansas, USA


Related Activities:

Organized International Cancer Vaccine Symposium 2012, Firenze, Italy

2008, New York, USA

2007, Vienna, Austria

2006, Washington DC, USA

2004, London, U.K.

2003, Beijing, China

2001, Tokyo, Japan

Clinical Research of Chinese Medicine (Immuno-Hasumi) in China since 2002

Clinical Research of Hasumi Vaccine in Brazil 1998

Cancer Preventive Research Project 1996 (Uremia Project) by Hasumi Vaccine with Tehran University, Ministry of Health, Iran.


Research Affiliations:

University of Maryland, USA Thomas Jefferson University, USA

The Institute of Medical Science, the University of Tokyo, Japan

National Institute of Health

Tokai University, Japan

Saitama Medical School Japan

Chaoshung Chinese Medical University, China

Jilin Provincial Cancer Hospital, China

Teikyo University, Japan

Taipei Medical University

School of Chinese Pharmacology, Beijing University of Chinese Medicine National University Of Malaysia (HUKM) Meiji Pharmaceutical University


Memberships (current and past):

Japan Cancer Society, Japan Surgical Society, Japan Society for Immunology

British Royal Society of Medicine

Association for Palliative Medicine of Great Britain and Ireland

European Association for Palliative Care



Title: Dendritic Cell Tumor Injection (DCTI) Therapy

USA (2015 No. 9,089,593 B2, 2011 No. 8,076,132 B2) Mexico (2012 No. 2007/003230), Singapore (2009 No.130719)

Title: Antigen Peptide And Use Thereof

China (2013 No IP1137027P), Japan (2013 No. 5243624), Euro (2012

No. EP2430157),

Title: Human Lymphocyte Medium Adjuvant

USA (2010 No. 7,745,157 B2), India 2009 No. 236395)



  1. Kenichiro Hasumi, Yukimasa Aoki, Ryuko Watanabe and Dean L. Mann. Clinical resonse of advanced cancer patients to cellular immunotherapy and intensity-modulated radiation therapy. OncoImmunology 2:10, e26381 (2013).
  2. Kenichiro Hasumi, Yukimasa Aoki, Ryuko Watanabe, Kim Hankey and Dean L. Mann. Therapeutic Response in Patients with Advanced Malignancies Treated with Combined Dendritic Cell-Activated T Cell Based Immunotherapy and Intensity-Modulated Radiotherapy. Cancers 2011, 3, 2223-2242 (2011).
  3. Kenichiro Hasumi. Combining Conventional Therapies with Intratumoral Injection of Autologous immature Dendritic Cells (iDC) and Activated T Cell (AT) Therapy for Advanced Cancer Treatment. Integrative Medicine Japan. Vol. 3, No. 1:47-55 (2010).
  4. Dean L. Mann, Christina M. Celluzzi, Kim Hankey, Kristina M. Harris, Ryuko Watanabe, and Kenichiro Hasumi. Combining Conventional Therapies with Intratumoral Injection of Autologous Dendritic Cells and Activated T Cells to Treat Patients with Advanced Cancers. Cancer Vaccines: Ann. N.Y. Acad. Sci. 1174:41-50 (2009).
  5. Chin-Hsuan Hsieh, Ya-Jan Hsu, Chien-Chung Chang, Hsin-Chun Liu, Kun-Lung Chuang, Cheng-Keng Chuang, See-Tong Pang, Kenichiro Hasumi, Soldano Ferrone, Shuen-Kuei Liao. Total HLA class I loss in a sarcomatoid renal carcinoma cell line caused by the coexistence of distinct mutations in the two encoding (β2-microglobulin genes. Cancer Immunology Immunotherapy 58, 395-408 (2008).
  6. Kristina M. Harris, Petra Lenz, Kim Hankey, Thomas MacVittie, Ann Farese, Kaori Nakajima, Kenichiro Hasumi and Dean L. Mann. Product of anti-CD3/anti-CD28 activated lymphocytes induce differentiation and maturation of dendritic cells and have adjuvant-like activity in vitro and in vivo. Clinical Immunology 129, 58-68 (2008).
  7. Hasumi, Saigo Made Akiramenai Kanjyasan E, Saigo Made Akiramenai Isi Kara Okuru Aino Ganwakuchin. (2007).
  8. Hasumi, Meneki Ryoku De Gan To Tatakau. (2005).
  9. Sato, M. Terai, R. Yasuda, R. Watanabe, D. Berd, M. Mastrangelo, K. Hasumi. Combination of monocyte-derived dendritic cells and activated T cells which express CD40 ligand: a new approach to cancer immunotherapy. Cancer Immunology 53, 53-61 (2004).
  10. T. Harmison, K. Hasumi. Cancer Vaccines Zeroing in on the Cancer Cell (2002).
  11. Hasumi, Lovely Cancer Vaccine II. (2002).
  12. Sekiguchi, Y. Shiroko, T. Arai, T. Kishino, T. Sugawara, T. Kusakabe, T. Suzuki, T. Yamashita, T. Obara, K. Ito, K. Hasumi. Biological Characteristic and chemosensitivity profile of four human anaplastic thyroid carcinoma cell lines. Biomed Pharmacother 55,466-74 (2001).
  13. Hirota, M. Haida, F. Mohtarami, K. Takeda, T. Iwamoto, S. Shioya, C. Tsuji, K. Hasumi, H. Nakazawa. Implication of ESR signals from ceruloplasmin (Cu2 * and transferrin (Fe3 * ) in pleural effusion of lung diseases. Pathophysiology 7, 41-45 (2000).
  14. Fujii, H. Iwasa, J. Hirai, Y. Takahama, K. Hasumi, M. Eriguchi. Inhibition of Liver metastases and tumor cell invasion in spontaneous liver metastasis model (LMFS) by sodium D-glucaro-5-lactam (ND2001). Biomed & Pharmacother 54, 85-92 (2000).
  15. Fujii, H. Iwasa, J. Hirai, K. Hasumi, M. Eriguchi, Effects of HCFU and TNP470 on liver metastasis of BALB/c retroperitoneal sarcoma. Gan to Kagaku Ryoho, 23-13 (1999).
  16. Terai, R. Yasuda, R. Watanabe, K. Hasumi and H. Wago. Evaluation of Boving Spleen Alcoholic Extract on Survival of Tumor-Bearing Mice. Bull SMSJC, Vol.8, 13-18 (1997).
  17. Fujii, H. Itoyanagi, I. Hirose, K. Hasumi, M. Eriguchi, Chaacterization of spontaneous liver metastatic model of BALB/c retroperitoneal sarcoma (LMFS) injected in footpad and antitumor effects of HCFU. Gan To Kagaku Ryoho, 24, 343-8 (1997).
  18. Takeda, M. Haida, S. Shinoya, T. Matsumori, Y. Kimura and K. Hasumi. Estimation of the Malignancy of Pleural Effusions by Electron Spin Resonance. Anal. Biochem., 241, 47-50 (1996).
  19. H. Yanagie, Y. Fujii, Y. Takeda, S. Mikamo, I. Yoshizaki, N. Akiyama, M. Eriguchi and K. Hasumi.
    Report of a case of Cystadenocartinoma of the liver treated with extended left lobectomy. J. Cancer Clin., 41, 1811-1816 (1995).
  20. K. Takeda, M. Haida, S. Shioya, T. Matsumori, Y. Kimura and K. Hasumi. Electron spin resonance of pleural effusions obtained from cancer and non cancer patients. Magnt. Resn. in Medicine, 6, 246-248 (1995).
  21. M. Sekiguchi, Y. Fujii, A. Saito, T. Suzuki, Y. Shiroko, H. Nakamura and K. Hasumi. lpha-fetoprotein-producing gastric carcinoma: Biological properties of a cultured cell line. J. Gastroenterol, 30, 589-598 (1995).
  22. Y. Fujii, H. Itoyanagi, Y. Saegusa, K. Hasumi and M. Eriguchi. Effect of 5'-DFUR against BALB/c retroperitoneal sarcoma with spontaneous liver metastases. Cancer & Immunotherapy, 21, 1627-1631 (1994).
  23. Y. Fujii, K. Hasumi and M. Eriguchi. A case of small intestinal cancer with tubular adenoma. Oncologia, 27, 462-465 (1994).
  24. Fujii, T. Takahashi, Y. Takeda, K. Hasumi and M. Eriguchi. A case report of primary squamous cell carcinoma of the breast. Oncologia, 27, 71-74 (1994).
  25. Fujii, H. Itoyanagi, Y. Saegusa, M. Kuro-o, Y. Matsuda, Y. Shiroko, M. Eriguchi and K. Hasumi. Establishment and characterization of BALB/c retroperitoneal Sarcoma with spontaneous liver metastases. Jpn. J. Cancer Res., 84, 1055-1061 (1993).
  26. Y. Takahama, Y. Fujii, H. Itoyanagi, H. Shimizu, M. J. Escribano, M. Eriguchi and K. Hasumi. Purification and molecular characterization of reto-acinar pancreatic protein (FAP). Oncologia, 26, 587-593 (1993).
  27. Nakamura, A. Masunaga, T. Yoshitake, K. Hasumi, S. Itoyama and I. Sugawara. Immunoelectron microscopic study of the lymphoid follicles in the thymus gland obtained from patients with Myasthenia gravis. J. Clin. Electron Microscopy, 25, 5-6 (1992).
  28. Takeda, M. Haida, T. Matsumori, Y. Kimura, and K. Hasumi. Detection of stable radicals in malignant ascites and pleural effusion by electron spin resonance. Proc. Faculty Science, Tokai Univ., 27, 63-72 (1992).
  29. Fujii, K. Hasumi, H. Nakamura, Y. Takahama, H. Shimizu, I. Sugawara, M. Eriguchi and M. Sekiguchi. Characterization of a murine monoclonal antibody, 5D-4, reacting with pancreatic cancers and islets of langerhans. Biomed & Pharmacother, 46, 405-411 (1992).
  30. Yanagie, T. Tomita, H. Kobayashi, Y. Fujii, T. Takahashi, K. Hasumi, H. Nariuchi, and M. Sekiguchi. Application of boronated anti-CEA immunoliposome to tumor cell growth inhibition in in vitro boron neutron capture therapy model. Br. J. Cancer, 63, 522-526 (1991).
  31. Fujii, Y. Yoshida, H. Shimizu, Y. Takahama, M. Eriguchi and K. Hasumi. The clinical significance of pancreatic cancer associated antigen 1H1 in cancer of pancreas-a comparative study with CA19/9 and CEA-. Oncologia, 24, 94-102 (1991).
  32. Kozai, Y. Fujii, M. Eriguchi, H. Shimizu, N. Akiyama, Y. Samaru, M. Sekiguchi, H. Uchida, T. Wakabayashi, S. Mori, T. Takahashi and K. Hasumi. Two Cases of villous adenoma of sigmoid colon with focal carcinomas. Oncologia, 24-5, 108-112 (1991).
  33. Hasumi, Lovely Cancer Vaccine. (1991).
  34. Nakamura, Y. Takahama, I. Sugawara, Y. Fujii, K. Hasumi and S. Itoyama. Cellular and tissue localization of antigens recognized by 5D-4 murine monoclonal antibody reactive with human langerhans' islands. J. Clin. Electron Microscopy, 23, 5-6 (1990).
  35. Nakamura, Y. Morishita, I. Sugawara, Y. Fujii, K. Hasumi and S. Mori. Ultrastructural localization of antigens recognized by 5D-4 monoclonal antibody reactive with islets of langerhans, J. Clin. Electron Microscopy, 23, 393-398 (1990).
  36. Hasumi, Ikiru. (1985)