Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

Официальное название

A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

Обзор

This study represents a phase I clinical trial that utilizes natural killer (NK) cell therapy for patients diagnosed with liver cancer, specifically those classified as Child-Pugh A and falling within the Barcelona Clinic Liver Cancer (BCLC) stages B or C. The expected results include determining the suitable treatment dosage, identifying any resulting side effects, and calculating the average duration of progression-free survival. The target group for the study consists of all individuals diagnosed with liver cancer. At the same time, the practical sample consists of those who received medical care for liver cancer at Cipto Mangunkusumo Hospital (RSCM) between May and December 2022. The chosen research sample comprises liver cancer patients who fulfill the predetermined participation criteria. The necessary sample size for discerning appropriate treatment dosages and the occurrence rate of potential side effects shall consist of 2-3 liver cancer patients who are administered autologous NK cells. The process for isolating these NK cells adheres to the guidelines established by Miltenyi Biotec.

Вмешательства

• Препарат Autologous Natural Killer Cell Therapy
  The therapy will be administered intravenously
• Устройство Clinimacs Plus
  The CliniMACS Plus device is an automated cell separation tool that uses MACS Technology. It incorporates a flexible system designed for isolating clinically labeled cells using MicroBeads.

Первичные конечные точки

• Optimal treatment dosage [Срок оценки: Start of infusion of Autologous NK cells (Day 0) until up to 6 months]

Вторичные конечные точки (4)

• Tumor Shrinkage [Срок оценки: Up to 6 months]
• Immunological Responses [Срок оценки: Up to 6 months]
• Hematology Profile [Срок оценки: Start of infusion of Autologous NK cells (Day 0) until up to 6 months]
• Progression-free survival [Срок оценки: Start of infusion of Autologous NK cells (Day 0) until progressive disease or death, whichever comes first, up to 2 years]

Критерии участия

Критерии включения

• Patients aged 20-60 years old
• Patients with Hepatocellular Carcinoma (HCC) staged as BCLC B and C
• Karnofsky Performance Status (KPS) score ≥ 70
• Expected patient survival of more than three months
• The following parameters are within the normal range:

Platelet count ≥ 80,000/µL White blood cell count ≥ 3000/µL Neutrophil count ≥ 2000 Hemoglobin ≥ 9 mg/dL International Normalized Ratio (INR) 0.8-1.5 Adequate liver function (bilirubin < 2, SGOT and SGPT < 60 U/L) Adequate kidney function (serum creatinine < 1.3, serum urea < 10)

Критерии исключения

• Refusing to participate in the study
• Afflicted by other malignancies, whether non-HCC liver or other malignancies
• Patients are affected by other conditions such as hypertension, severe coronary disease, myelosuppression, respiratory disorders, and acute or chronic infections
• Patients who have previously undergone transplantation and received other stem cell therapies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Cipto Mangunkusumo General Hospital — Jakarta Pusat

Идентификаторы

NCT: NCT06044506 · 22080996

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗