Esophageal adenocarcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants at least 18 years of age on the date of signing the Informed Consent Form; male or female participants with histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma or esophageal adenocarcinoma; participants initiating treatment with an anti-programmed cell death protein 1 or anti-programmed death-ligand 1 agent; Eastern Cooperative Oncology Group performance status of 0 or 1
Exclusion criteria
Exclusion criteria: Absence of tumor tissue in paraffin block for immunohistochemical analysis; inability to collect blood samples for evaluation; history or current evidence of any medical condition, therapy, laboratory abnormality, or other circumstance that may confound the study results or interfere with participation throughout the study period, in a manner that is not in the participant's best interest, according to the assessment of the investigator responsible for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate event-free survival. The outcome will be assessed through clinical and radiological follow-up of participants. An event will be defined as local, regional, or distant radiological recurrence assessed by the investigator, clinical recurrence with histopathological confirmation, or death from any cause. The time elapsed between randomization and the first event during the study follow-up period will be measured.;To evaluate overall survival. The outcome will be assessed through clinical follow-up of participants. The time elapsed between randomization and death from any cause during the study follow-up period will be measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
BR
Contacts
Hospital Nossa Senhora da Conceição S.A.