Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
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
| Condition(s) | Hepatocellular Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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 crit |
| Who can participate | 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, myelos |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Lead sponsor | Dr Cipto Mangunkusumo General Hospital |
| Locations | Jakarta Pusat, Jakarta Special Capital Region, Indonesia |
| Start date | 2022-08-29 |
| NCT ID | NCT06044506 |
| Official listing | https://clinicaltrials.gov/study/NCT06044506 |