RT Journal Article
SR Electronic
T1 Adoptive immunotherapy with natural killer cells from peripheral blood CD34<sup>+</sup> stem cells to prevent hepatocellular carcinoma recurrence after curative hepatectomy: a study protocol for an open-label, single-arm phase I study
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e064526
DO 10.1136/bmjopen-2022-064526
VO 12
IS 11
A1 Ohira, Masahiro
A1 Kobayashi, Tsuyoshi
A1 Tanaka, Yuka
A1 Imaoka, Yuki
A1 Sato, Koki
A1 Imaoka, Koki
A1 Nakano, Ryosuke
A1 Doskali, Marlen
A1 Piao, Jinlian
A1 Nakamura, Mayuna
A1 Yoshida, Tetsumi
A1 Ichinohe, Tatsuo
A1 Kawano, Reo
A1 Yoshimura, Kenichi
A1 Ueda, Keiko
A1 Tamura, Natsuko
A1 Hirata, Taizo
A1 Imamura, Michio
A1 Aikata, Hiroshi
A1 Tanimine, Naoki
A1 Kuroda, Shintaro
A1 Tahara, Hiroyuki
A1 Ide, Kentaro
A1 Ohdan, Hideki
YR 2022
UL http://bmjopen.bmj.com/content/12/11/e064526.abstract
AB Introduction Hepatocellular carcinoma (HCC) remains a major clinical problem as more than half of these cases recur after radical resection. Natural killer (NK) cells are at the forefront of the innate immune system and attack microcarcinomas and circulating tumour cells. The objective of this study was to evaluate the feasibility and toxicity of peripheral blood CD34+ stem cell-derived NK cell infusion after radical hepatectomy for HCC.Methods and analysis This is an open-label, single-arm, single-centre phase I study. Patients who have undergone initial hepatectomy for HCC with three or more risk factors for recurrence (≥10 ng/mL of Alpha fetoprotein (AFP), ≥360 mAU/mL of PIVKA-II, multiple tumours and ≥3 peripheral blood circulating tumour cells) will be enrolled and be treated with three peripheral blood CD34+ stem cell-derived NK cell infusions every 3 months. The primary endpoint will be safety assessment including the type and severity of adverse events, frequency of occurrence and duration of occurrence. The secondary endpoints will include survival, effect of immune response and clinical laboratory test results.Ethics and dissemination Ethical approval of the trial was obtained from the Certified Committee for Regenerative Medicine Hiroshima University in Japan. The trial results will be shared with the scientific community at international conferences and by publication in a peer-reviewed journal.Trial registration number jRCTb060200020.