Nasopharyngeal Carcinoma (NPC)
Conditions
Keywords
NPC, ICB, asparaginase
Brief summary
The goal of this study is to investigate the outcomes of patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC) or recurrent-metastatic nasopharyngeal carcinoma (RM-NPC) treated with a combination of immune checkpoint blockade (ICB) and asparaginase.
Detailed description
This study is being conducted to investigate the synergistic effect of combining asparaginase with immune checkpoint blockade (ICB) in tumor-bearing mice. Findings indicate that asparaginase enhances CD8+ T cell activation, and previous reports have shown that nasopharyngeal carcinoma (NPC) patients exhibit a lower response rate to ICB treatment. This study aims to determine whether the combination therapy of asparaginase and ICB is more effective or less effective compared to the standard ICB-only approach for patients with locoregionally advanced (LA-NPC) or recurrent-metastatic NPC (RM-NPC). Participants are being enrolled who have previously received ICB but continue to experience disease progression.
Interventions
DRUGAnti-PD1
Pembrolizumab 100mg in normal saline 100ml infusion over 30 minutes for every two month
DRUGasparaginase
The patients will receive asparaginase 10000IU/vail IM QD for three or five days.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients who have previously received immune checkpoint blockade therapy but are still experiencing disease progression -
Exclusion criteria
Active autoimmune disease \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Analysis of Plasma EBV DNA Levels for Treatment Response | Until the end of the study | In nasopharyngeal carcinoma (NPC), plasma Epstein-Barr virus (EBV) DNA serves as a crucial biomarker for both diagnosis and monitoring. EBV, a herpesvirus that infects epithelial cells, is strongly associated with NPC development, especially in endemic regions. The transformation from latent EBV infection to active viral replication is considered a critical step in NPC pathogenesis. This transformation can be detected through circulating viral DNA levels in plasma or by measuring antibodies against various EBV antigens, such as EBNA1, VCA, and EA-D. Elevated EBV DNA levels often correlate with tumor burden and may serve as a predictor of NPC recurrence or progression. Consequently, plasma EBV DNA testing has become an essential tool in NPC clinical management, helping to guide treatment decisions and evaluate treatment response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FDG PET/CT scan | 3 month | FDG PET/CT for detecting tumor existence |
Countries
Taiwan
Outcome results
None listed