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Adjuvant nivolumab in patients with esophageal cancer: The planning of scanning

Adjuvant nivolumab in patients with esophageal cancer: The planning of scanning - Adjuvant nivolumab in patients with esophageal cancer: The planning of scanning

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57882
Enrollment
150
Registered
2025-06-12
Start date
2024-12-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Not applicable, retrospective study

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: diagnosis of esophageal or esophageal junction cancer; completed esophageal or gastroesophageal resectioneligible for adjuvant nivolumab (i.e. received neo-adjuvant chemoradiation, surgical margin is microscopically negative for residual tumor, incomplete pathological response and no contra indications for immune therapy as considered by their treating physician)

Exclusion criteria

Exclusion criteria: Complete pathological response in resection specimenIrradical surgical resection marginsOther neoadjuvant treatment than neoadjuvant chemoradiotherapy (i.e. perioperative chemotherapy, definitive chemoradiotherapy) Contra-indications for immune therapy (e.g. auto-immune disorders, low performance status) leading to not starting adjuvant nivolumab

Design outcomes

Primary

MeasureTime frame
To assess the proportion of patients with locoregional and/or distant metastasis, as detected at baseline CT and at different time points during adjuvant Nivolumab.

Secondary

MeasureTime frame
Secondary outcomes include the method of detection of disease recurrence 

Countries

Netherlands

Contacts

Public ContactT.J. Huizer

Erasmus Universiteit Rotterdam

t.j.huizer@erasmusmc.nl0107034523

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)