Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving adjuvant nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | As per product label, as prescribed by treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant disease-free survival (DFS) | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Participant socio-demographics | Baseline and up to 1 year | |
| Date of tumor initial diagnosis | Baseline | |
| Tumor location at initial diagnosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Shanghai | 200030 | China |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline |
| Tumor histology at initial diagnosis | Baseline |
| Resected tumor margins status | Negative (clear), positive (involved), close margins | Baseline |
| Eastern Cooperative Oncology Group (ECOG) performance status | Baseline and up to 1 year |
| Pathological lymph-node status | Baseline and up to 1 year |
| Pathological tumor status | Baseline and up to 1 year |
| Participant biomarkers (if available) | Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis | Baseline and up to 1 year |
| Participant outcomes after nivolumab treatment | Including disease stage, recurrence, disease progression, medical imaging test result, and death information | Baseline and up to 1 year |
| Participant medical history | Baseline and up to 1 year |
| Participant cancer treatment history | Baseline |
| Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation | Day 1 |
| Indication for nivolumab treatment | Day 1 |
| Nivolumab treatment duration | Up to 1 year |
| Time from surgery to nivolumab initiation | Day 1 |
| Nivolumab treatment regimen | Up to 1 year |
| Participant concomitant treatment(s) | Baseline and up to 1 year |
| Participant systemic treatment(s) | Up to 1 year |
| Date of nivolumab treatment completion/discontinuation | Up to 1 year |
| Reasons for treatment discontinuation/cessation | Up to 1 year |
| Subsequent treatment after nivolumab discontinuation | Up to 1 year |
| Time to next treatment (TTNT) | Up to 1 year |
| Nivolumab treatment modifications in relation to the management of adverse events (AE) | Up to 1 year |
| Participant distant metastasis-free survival (DMFS) | Up to 1 year |
| Participant distant metastasis-free survival (DMFS) rates | Up to 1 year |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |