Actively Recruiting
Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Led by Dr Cipto Mangunkusumo General Hospital · Updated on 2023-09-26
3
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Platelet count 80,000/b5L
- White blood cell count 3000/b5L
- 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)
You will not qualify if you...
- Refusing to participate in the study
- Having other malignancies besides hepatocellular carcinoma
- Having hypertension, severe coronary disease, myelosuppression, respiratory disorders, or acute or chronic infections
- Previous organ transplantation or prior stem cell therapies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cipto Mangunkusumo General Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
Actively Recruiting
Research Team
A
Ardhi Rahman Ahani, MD
CONTACT
F
Firshan Makbul, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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