Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Natural Killer Cell Therapy, Clinimacs Plus.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Overview
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.
Interventions
- Drug Autologous Natural Killer Cell Therapy
The therapy will be administered intravenously - Device 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.
Primary outcome measures
- Optimal treatment dosage [Time frame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months]
Secondary outcome measures (4)
- Tumor Shrinkage [Time frame: Up to 6 months]
- Immunological Responses [Time frame: Up to 6 months]
- Hematology Profile [Time frame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months]
- Progression-free survival [Time frame: Start of infusion of Autologous NK cells (Day 0) until progressive disease or death, whichever comes first, up to 2 years]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- Cipto Mangunkusumo General Hospital — Jakarta Pusat
Identifiers
NCT: NCT06044506 · 22080996