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Brief Title: Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Official Title: A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Study ID: NCT06044506
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.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Cipto Mangunkusumo General Hospital, Jakarta Pusat, Jakarta, Indonesia
Name: Cosphiadi Irawan, MD, PhD
Affiliation: Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
Role: PRINCIPAL_INVESTIGATOR