Prospective Evaluation of Nivolumab in Adjuvant Esophageal Carcinoma/Gastroesophageal Junction Carcinoma: A Non-interventional Study

Brief Summary

Primary Outcomes

Secondary Outcomes

• Time To Next Treatment(From baseline up to 42 months)
• DFS in Subgroups of Interest(Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first)
• Post-recurrence Survival(Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first)
• Type of Disease Recurrence(From baseline up to 42 months)
• Participant Sociodemographics(From baseline up to 42 months)
• Overall Survival (OS)(Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first)
• DMFS Rates(From baseline up to 42 months)
• OS Rates(From baseline up to 42 months)
• PFS Rates(From baseline up to 42 months)
• PFS for Participants That Received Subsequent Nivolumab Treatment(Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first)
• Time to Disease Recurrence(From baseline up to 42 months)
• Eastern Cooperative Oncology Group (ECOG) performance status(From baseline up to 42 months)
• Comorbidities(From baseline up to 42 months)
• DFS Rates in Subgroups of Interest(From baseline up to 42 months)
• Progression-free Survival (PFS)(Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first)
• Treatment Patterns of Adjuvant Nivolumab(From baseline up to 42 months)
• Treatment Patterns of Subsequent Therapy(From baseline up to 42 months)
• Number of participants with metastasis(From baseline up to 42 months)
• Concomitant treatments(From baseline up to 42 months)
• Prior treatments for EC/GEJC(From baseline up to 42 months)
• Distant Metastasis-free Survival (DMFS)(Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first)
• OS Rates for Participants That Received Subsequent Nivolumab Treatment(From baseline up to 42 months)
• Disease stage at initial diagnosis(From baseline up to 42 months)
• Tumor location at initial diagnosis(From baseline up to 42 months)
• Tumor histology at initial diagnosis(From baseline up to 42 months)
• Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable)(From baseline up to 42 months)
• Number of Participants with Serious Adverse Events Related to Nivolumab Treatment(From baseline up to 42 months)
• Sites of metastases(From baseline up to 42 months)
• Concurrent medical conditions(From baseline up to 42 months)
• OS for Participants That Received Subsequent Nivolumab Treatment(Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first)
• PFS Rates for Participants That Received Subsequent Nivolumab Treatment(From baseline up to 42 months)
• Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment(From baseline up to 42 months)
• Number of Participants with Adverse Events(From baseline up to 42 months)
• Pathologic lymph node status(From baseline up to 42 months)
• Pathologic tumor status(From baseline up to 42 months)
• Type of recurrence(From baseline up to 42 months)
• Serum levels of nuclear protein Ki67(From baseline up to 42 months)
• Participant Treatment History(From baseline up to 42 months)