Status:
WITHDRAWN
Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)
Lead Sponsor:
Samsung Medical Center
Conditions:
Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 ass...
Eligibility Criteria
Inclusion
- Patients must be ≥20 years of age.
- Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second-line therapy.
- The patient's tumor tissue must have the pre-defined characteristics as follows ; EBV+
- ECOG performance status 0-1
- Patients must have a life expectancy ≥ 4 months from proposed first dose date.
- The patient has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below: WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 9 g/dL (transfusion allowed), Platelet count ≥ 100,000 /mm3; Total bilirubin ≤ 1.5 X ULN, AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN; Creatinine clearance ≥60 mL/min
- Provision of fully informed consent prior to any study specific procedures.
Exclusion
- The patient has a history severe or unstable heart disease, e.g. coronary artery disease requiring increased dose of anti-anginal medication and/or coronary angioplasty (including stent placement) within 24 months ( congestive heart failure NYHA III or IV, unstable angina, history of myocardial infarction within the last 12 months, clinically significant arrhythmia)
- The patient is pregnant or breastfeeding.(For women with pregnancy potential, an effective method of contraception should be agreed.)
- The patient has ongoing Uncontrolled systemic diseases (diabetes, hypertension, hypothyroidism, infection, etc.)
- The patient has ongoing central nervous system malignancy. (except for lesions that have been completely removed or underwent anterior brain radiotherapy/gamma knife procedure)
- The patient has a history of allergic reactions to gemcitabine, Valganciclovir, aciclovir, valacyclovir ganciclovir
- Patients with interstitial pneumonia or pulmonary fibrosis with clinical symptoms
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05431244
Start Date
July 1 2022
End Date
July 1 2024
Last Update
November 1 2022
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351