Safety and Effectiveness of Dendritic Cell Therapy in Nasopharyngeal Cancer Treatment
Tahapan Penelitian : Recruit
Sponsor:
PT Prodia StemCell Indonesia
Mitra Pelaksana:
Central Army Hospital Gatot Soebroto
No Registry
INA-9NZQZDLN
Tanggal Input Registry : 03-02-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 16-05-2024 |
| Outcome Primer | Evaluating the safety and effectiveness of the dendritic cell therapies (SD-Auto and SSD-Allo) in patients with nasopharyngeal carcinoma. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Safety and Effectiveness of Dendritic Cell Therapy in Nasopharyngeal Cancer Treatment |
| Judul Penelitian Ilmiah | Safety and Efficacy of Autologous Dendritic Cells (SD-Auto) and the Combination of Autologous Dendritic Cells (SD-Auto) with Allogeneic Dendritic Cell Secretome (SSD-Allo) as Adjuvant Therapy in Nasopharyngeal Carcinoma Patients with Partial Response and Stable Disease. |
| Jenis Penelitian | Interventional |
| Intervensi | Arm 2: Aqua Pro Injection 2cc via intramuscular injection, administered once and SD-Auto Therapy (1 x 10⁷ cells / 2 cc NaCl) via intramuscular injection, administered once. Arm 3: SSD-Allo Therapy (2 cc) via intramuscular injection, administered once and SD-Auto Therapy (maximum 1 x 10⁷ cells / 2 cc NaCl) via intramuscular injection, administered once. |
| Jumlah Subyek Penelitian | 15 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Men and women aged 18-60 years (LITBANGKES) 2. Primary diagnosis of Nasopharyngeal Carcinoma (NPC) 3. Receiving standard therapy, weekly Cisplatin as a sensitizer (40 mg/m²) and Radiotherapy (60-70 Gy) (LITBANGKES). 4. Having partial response or stable disease (RECIST). 5. Able to understand the nature of the study, willing to sign informed consent, and capable of cooperating with follow-up treatment.Exclusion Criteria: 1. Pregnant women, those planning to become pregnant, or breastfeeding 2. Having completed or progressive disease (RECIST). 3. Having a history of drug allergies and transfusion reactions. 4. Having lab results showing Hb < 10g%, creatinine clearance < 40 ml/min, serum bilirubin > 1.5x above normal, SGPT – SGOT > 5x above normal. 5. Undergoing immunosuppressive treatment such as corticosteroids. 6. Diagnosed with positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). |
| Administrative Information | |
| Nomor Persetujuan Etik | 60/IV/KEPK/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Rima Haifa, S.Si, M. Farm-Klin |