NCT06044506RecruitingPhase 1
Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 26 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (estimated)
- First submitted
- 1 Sept 2023
- Start date
- 29 Aug 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06044506
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 3
- From 29 Aug 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously undergone transplantation and received other stem cell therapies
Other illness
- 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
Other
- Refusing to participate in the study
Who the study is looking for
- 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)
Age in the registry: 20 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cipto Mangunkusumo General Hospital Coordinator of this site? Confirm its status | Jakarta Pusat | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.