臨床研究等提出・公開システム

A Phase I Physician-Initiated Clinical Trial to Evaluate the Safety of Postoperative Immunotherapy Using Donor Liver-Derived Activated Natural Killer (NK) Cells in High-Risk Groups for Recurrence Following Liver Transplantation for Hepatocellular Carcinoma

A Phase I Physician-Initiated Clinical Trial to Evaluate the Safety of Postoperative Immunotherapy Using Donor Liver-Derived Activated NK Cells in High-Risk Groups for Recurrence Following Liver Transplantation for HCC

Ohdan Hideki

Hiroshima University Hospital

1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551 JAPAN

nk-administrator@ml.hiroshima-u.ac.jp

Ohira Masahiro

Hiroshima University Hospital

1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551 JAPAN

+81-82-257-5222

nk-administrator@ml.hiroshima-u.ac.jp

Recruiting

Sept. 01, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Select patients who meet all of the criteria listed below.
1) Patients who are 18 years of age or older at the time of consent acquisition;
2) Patients for whom written consent to participate in this clinical trial has been obtained from the patient or a legal representative;
3) Patients diagnosed with hepatocellular carcinoma based on imaging, histology, biopsy, or cytology;
4) Patients with concomitant decompensated cirrhosis (Child-Pugh score of 7 or higher);
5) Patients who meet the following conditions and are scheduled to undergo living-donor partial liver transplantation:
i) Japan Criteria: Meet either the Milan Criteria (HCC <= 3 cm and <= 3 lesions, or HCC <= 5 cm and a single lesion) or the 5-5-500 Criteria (<= 5 cm, <= 5 lesions, and AFP <= 500 ng/mL)
ii) No evidence of metastasis to other organs
iii) Medical treatment has been ineffective;
6) For women who may become pregnant (including patients without menstruation due to medical reasons such as chemical menopause), those who have confirmed a negative pregnancy test result within 14 days prior to surgery and who have agreed to use dual contraception for one year following consent to participate in this clinical trial and to refrain from breastfeeding.
For men, patients who have agreed to use contraception for one year from the date of cell administration.

Patients who meet any of the following criteria shall be excluded from the study.
1) Patients who have previously undergone a liver transplant
2) Patients undergoing a brain-dead donor liver transplant
3) Patients with concurrent cancers (Patients with completely resected basal cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or patients with other cancers for which no recurrence has been observed for at least 5 years prior to obtaining informed consent, are eligible for enrollment)
4) Patients with a history of severe thrombosis or thromboembolism, excluding portal vein thrombosis. However, patients for whom at least 90 days have elapsed since the event and who are not at risk of recurrence may be enrolled.
5) Patients currently receiving concurrent antitumor therapy. Or patients who have received systemic therapy (chemotherapy, targeted therapy, antibody therapy, hormone therapy, or immunotherapy) within 90 days prior to enrollment.
6) Patients with severe heart disease.
7) Patients with current or past interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis diagnosed by imaging.
8) Patients with severe renal impairment (requiring dialysis).
9) Patients with a systemic infection requiring treatment.
10) Patients with uncontrolled diabetes.
11) Patients who are pregnant, breastfeeding, or who may be pregnant;
12) Patients deemed to lack the capacity to give informed consent due to conditions such as dementia;
13) Patients with a history of hypersensitivity to mice;
14) Any other patients whom the principal investigator deems unsuitable for participation in this clinical trial;

Both

Patients with HCC and decompensated cirrhosis requiring living-donor liver transplantation

On the fifth day after living donor liver transplantation, NK cells are administered intravenously over 30 minutes to 1 hour. Only a single dose is administered. In this clinical trial, the collected and processed cells will be formulated into the following two final product formulations:
Low-dose group: 50 x 10^6 cells, volume 100 mL, concentration 0.5 x 10^6/mL
High-dose group: 200 x 10^6 cells, volume 100 mL, concentration 2.0 x 10^6/mL

Hepatocellular Carcinoma, Living-Donor Liver Transplantation, Decompensated Cirrhosis

Safety at 3 Months After Liver Transplantation (Incidence and Severity of Adverse Events Following NK Cell Administration)

1) Safety during the first year after liver transplantation (incidence and severity of adverse events following NK cell administration)
2) Overall survival (6 months and 1 year post-surgery)
3) Effects on the immune response
-Evaluation of donor-specific immune response using CFSE-MLR (1, 2, and 4 weeks post-surgery)
-Occurrence of rejection events
-Evaluation of recipient peripheral blood NK cell activity
4) Occurrence and timing of hepatocellular carcinoma recurrence
5) Occurrence of infections (bacterial infections, cytomegalovirus infections, fungal infections, etc.)

+81-82-257-5596

Mar. 02, 2026

No

none