drugset / Trial / NCT05431244

Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)

NCT05431244

NaSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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

Indications