Status:

RECRUITING

Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

Lead Sponsor:

Dr Cipto Mangunkusumo General Hospital

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

20-60 years

Phase:

PHASE1

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 29 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT06044506

Start Date

August 29 2022

End Date

December 1 2026

Last Update

September 26 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Cipto Mangunkusumo General Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430