Using natural killer cell therapy to treat liver cancer
A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
This study is testing a new therapy using natural killer cells to see if it can help people with liver cancer feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Dr Cipto Mangunkusumo General Hospital Academic / other |
| Locations | 1 site (Jakarta Pusat, Jakarta Special Capital Region) |
| Trial ID | NCT06044506 on ClinicalTrials.gov |
What this trial studies
This phase I clinical trial investigates the use of autologous natural killer (NK) cell therapy for patients diagnosed with hepatocellular carcinoma (HCC) classified as Child-Pugh A and within Barcelona Clinic Liver Cancer (BCLC) stages B or C. The study aims to determine the appropriate treatment dosage, assess any side effects, and evaluate the average duration of progression-free survival. Participants will be recruited from Cipto Mangunkusumo Hospital, focusing on those who meet specific eligibility criteria, including age and health status. The trial will involve a small sample size of 2-3 patients to gather preliminary data on the therapy's safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20-60 with hepatocellular carcinoma staged as BCLC B or C and a Karnofsky Performance Status score of 70 or higher.
Not a fit: Patients with other malignancies, severe comorbid conditions, or those who have previously undergone stem cell therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced liver cancer, potentially improving their survival outcomes.
How similar studies have performed: While NK cell therapy is a promising area of immunotherapy, this specific approach for hepatocellular carcinoma is still in early phases and has not been widely tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jakarta Pusat, Jakarta Special Capital Region
- Cipto Mangunkusumo General Hospital — Jakarta Pusat, Jakarta Special Capital Region, Indonesia (Recruiting)
Study contacts
- Principal investigator: Cosphiadi Irawan, MD, PhD — Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
- Study coordinator: Ardhi Rahman Ahani, MD
- Email: ardhi.ahani@gmail.com
- Phone: +62 87870171876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.