NCT06044506 Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
| NCT ID | NCT06044506 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dr Cipto Mangunkusumo General Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2022-08-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 3 participants in total. It began in 2022-08-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
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
Contact & Investigator
Cosphiadi Irawan, MD, PhD
PRINCIPAL INVESTIGATOR
Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
Frequently Asked Questions
Who can join the NCT06044506 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 60 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06044506 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06044506 currently recruiting?
Yes, NCT06044506 is actively recruiting participants. Contact the research team at ardhi.ahani@gmail.com for enrollment information.
Where is the NCT06044506 trial being conducted?
This trial is being conducted at Jakarta Pusat, Indonesia.
Who is sponsoring the NCT06044506 clinical trial?
NCT06044506 is sponsored by Dr Cipto Mangunkusumo General Hospital. The principal investigator is Cosphiadi Irawan, MD, PhD at Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia. The trial plans to enroll 3 participants.
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