NCT06361563
Completed
Not Applicable
Patients With Upper Gastrointestinal Cancer Enrolled in a Patient Support Program to Receive Nivolumab in the Adjuvant Setting: Real World Data From Canada
Overview
- Phase
- Not Applicable
- Intervention
- Nivolumab
- Conditions
- Upper Gastrointestinal Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Participant primary upper gastrointestinal cancer diagnosis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant nivolumab.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Enrolled in Bristol-Myers Squibb GastroEsophageal Opdivo in Resected Patients with Residual Pathological Disease Patient Support Program (GEORge PSP) in Canada
- •Patients who have consented to the use of their de-identified data generated from information collected in the course of the GEORge PSP
Exclusion Criteria
- •Aged \<18 years
- •Did not receive concurrent chemoradiotherapy prior to surgery
- •Positive margins following resection
- •No residual disease following complete resection
Arms & Interventions
Participants treated with adjuvant nivolumab
Intervention: Nivolumab
Outcomes
Primary Outcomes
Participant primary upper gastrointestinal cancer diagnosis
Time Frame: Baseline
Participant comorbidities
Time Frame: Baseline
Date of tumour resection
Time Frame: Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score
Time Frame: Baseline
Participant tumour location
Time Frame: Baseline
Participant sociodemographics
Time Frame: Baseline
Participant histology results
Time Frame: Baseline
Secondary Outcomes
- Number of nivolumab treatments received(Up to 484 days)
- Participant adverse events (AEs)(Up to 484 days)
- Initial nivolumab dosage prescribed to participants(Index date)
- Nivolumab treatment duration(Up to 484 days)
- Nivolumab dosage modification(Up to 484 days)
- Reason for participant discharge(Up to 484 days)
- Management of participant adverse events (AEs)(Up to 484 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in CanadaUpper Gastrointestinal CancerNCT06361576Bristol-Myers Squibb700
Not yet recruiting
Not Applicable
Prospective Observational Cohort StudyGastric CancerLiver MetastasesNCT06493448Lin Chen1,326
Withdrawn
Not Applicable
Electronic Patient Reported Outcomes in Patients With Gastrointestinal CancersGastrointestinal CancersGastrointestinal Cancer MetastaticNCT05359042University of California, San Francisco
Active, not recruiting
Not Applicable
GastroIntestinal Cancer in Children and AdolescentsGastrointestinal CancerColorectal CancerGastric CancerHepatoblastomaHepatocellular CarcinomaBurkitt LymphomaNeuroendocrine TumorsNCT05693519Paul G. Kemps, MD2,500
Recruiting
Not Applicable
A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing MethodGastric CancerOrganoidsNCT06100003Funan Liu104