Clinical trial NCT06499298: Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer
Official title: Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer: A Non-interventional Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Gastroesophageal Junction Cancer
Keywords: Esophageal Cancer (EC)
Gastroesophageal Junction Cancer (GEJC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult participants from China with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) who initiated nivolumab treatment in routine clinical practice between June 27, 2022 and October 31, 2023.

Brief summary: The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) in China.


Eligibility criteria: Inclusion Criteria:

* Participants aged 18 years or older at the index date
* All patients must have Stage II or Stage III carcinoma of the esophagus or gastroesophageal junction and have histologically or cytologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer at the time of initial diagnosis.
* Participants initiated nivolumab in adjuvant Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) treatment within the index window.

Exclusion Criteria:

* Participation in a clinical trial of an investigational drug concurrently during the adjuvant nivolumab treatment.
* From the date of diagnosis of EC or GJEC to data end period, patients were diagnosed with a primary diagnosis of a cancer other than EC or GJEC that requires systemic or other treatment

Primary outcomes:
measure: Participant disease-free survival (DFS)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Participant socio-demographics
timeFrame: Baseline and up to 1 year
measure: Date of tumor initial diagnosis
timeFrame: Baseline
measure: Tumor location at initial diagnosis
timeFrame: Baseline
measure: Tumor histology at initial diagnosis
timeFrame: Baseline
measure: Resected tumor margins status
timeFrame: Baseline
measure: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: Baseline and up to 1 year
measure: Pathological lymph-node status
timeFrame: Baseline and up to 1 year
measure: Pathological tumor status
timeFrame: Baseline and up to 1 year
measure: Participant biomarkers (if available)
timeFrame: Baseline and up to 1 year
measure: Participant outcomes after nivolumab treatment
timeFrame: Baseline and up to 1 year
measure: Participant medical history
timeFrame: Baseline and up to 1 year
measure: Participant cancer treatment history
timeFrame: Baseline
measure: Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation
timeFrame: Day 1
measure: Indication for nivolumab treatment
timeFrame: Day 1
measure: Nivolumab treatment duration
timeFrame: Up to 1 year
measure: Time from surgery to nivolumab initiation
timeFrame: Day 1
measure: Nivolumab treatment regimen
timeFrame: Up to 1 year
measure: Participant concomitant treatment(s)
timeFrame: Baseline and up to 1 year
measure: Participant systemic treatment(s)
timeFrame: Up to 1 year
measure: Date of nivolumab treatment completion/discontinuation
timeFrame: Up to 1 year
measure: Reasons for treatment discontinuation/cessation
timeFrame: Up to 1 year
measure: Subsequent treatment after nivolumab discontinuation
timeFrame: Up to 1 year
measure: Time to next treatment (TTNT)
timeFrame: Up to 1 year
measure: Nivolumab treatment modifications in relation to the management of adverse events (AE)
timeFrame: Up to 1 year
measure: Participant distant metastasis-free survival (DMFS)
timeFrame: Up to 1 year
measure: Participant distant metastasis-free survival (DMFS) rates
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: