KCT0003379
Active, not recruiting
未知
A phase III study to assess the immunogenicity and safety of PCV-13 during adjuvant chemotherapy
Chonnam National University Hospital Hwasun Hospital0 sites92 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Enrollment
- 92
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible patients (aged \= 19 years) had underwent surgical resection for primary gastric or colorectal cancer and scheduled for adjuvant chemotherapy (fluoropyrimidine ± oxaliplatin), an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, and adequate hematological, renal, hepatic function within 2 weeks of randomization (absolute neutrophil count \=1,500/mm3, platelet count \=100,000/mm3, serum creatinine \= 1\.5 X the upper limit of normal \[ULN] or estimated glomerular filtration rate \[eGFR] \> 50 mL/min calculated by Cockcroft\-Gault equation, serum aspartate aminotransferase \[AST] and alanine aminotransferase \[ALT] \= 3 X the ULN, and total bilirubin \= 2 X the ULN).
Exclusion Criteria
- •Exclusion criteria included previous pneumococcal vaccination, hypersensitivity to diphtheria toxin or other compounds of the vaccine, history of immunodeficiency disorders or autoimmune diseases, use of immunomodulatory drugs within 3 months of randomization, and signs of infection within 24 hours of vaccination.
Outcomes
Primary Outcomes
Not specified
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