jRCT2063260046招募中不适用
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
未提供0 个研究点目标入组 6 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Select patients who meet all of the criteria listed below.
- •Patients who are 18 years of age or older at the time of consent acquisition;
- •Patients for whom written consent to participate in this clinical trial has been obtained from the patient or a legal representative;
- •Patients diagnosed with hepatocellular carcinoma based on imaging, histology, biopsy, or cytology;
- •Patients with concomitant decompensated cirrhosis (Child-Pugh score of 7 or higher);
- •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;
- •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.
排除标准
- •Patients who meet any of the following criteria shall be excluded from the study.
- •Patients who have previously undergone a liver transplant
- •Patients undergoing a brain-dead donor liver transplant
- •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)
- •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.
- •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.
- •Patients with severe heart disease.
- •Patients with current or past interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis diagnosed by imaging.
- •Patients with severe renal impairment (requiring dialysis).
- •Patients with a systemic infection requiring treatment.
- •Patients with uncontrolled diabetes.
- •Patients who are pregnant, breastfeeding, or who may be pregnant;
- •Patients deemed to lack the capacity to give informed consent due to conditions such as dementia;
- •Patients with a history of hypersensitivity to mice;
- •Any other patients whom the principal investigator deems unsuitable for participation in this clinical trial;
研究者
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