NCT05431244

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Antiviral treatment in combination with low-dose gemcitabine	-maximun 6 cycles Gemcitabine; 30mg/m2 or 100mg/m2 or 300mg/m2 D1,D8, D15 (Q 1 week,3 times, rest for 1 week, every 4 weeks ) 1,2 cycle Valganciclovir; 900mg D8\~D28 (from 1 week after Gemcitabine iv started, qd, PO, 21days) 3\~6cycle Valganciclovir; 900mg D1\~D28 (from Gemcitabine start date, PO, 28days)

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-06-24
• Last updated: 2022-11-01

Locations

1 site across 1 country: South Korea