Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)
Summary
Epstein-Barr virus (EBV) is a double-stranded DNA human gamma herpes virus that establishes a persistent infection in over 90% of individuals. Most infections are self-limiting, but some cases are associated with the development of malignancies of lymphoid or epithelial origin. EBV-associated gastric carcinomas (EBVaGC) make up about 9% of all stomach cancers. The constant presence of the viral genome in EBVaGC suggests the applicability of novel EBV-targeted therapies. The antiviral nucleoside drug, (val)ganciclovir (GCV), is effective only in the context of the viral lytic cycle in the presence of EBV-encoded thymidine kinase (TK)/ protein kinase (PK) expression. JM Lee et al. reported that gemcitabine was lytic inducer via activation of the ATM/p53 genotoxic stress pathway in EBVaGC and confirmed the efficacy of gemcitabine-GCV combination treatment. So we planned this proof of concept trial to apply the antiviral agent in EBVaGC.
Timeline
- Start
- 2022-07-01
- Primary completion
- 2024-07-01
- Completion
- 2024-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 300 mg/m2 | Intravenous |
| Subject | Valganciclovir | Small molecule | 900 mg | Oral |