An observational study of the safety and efficacy of nivolumab as adjuvant treatment for esophageal cancer using the Comprehensive Registry of Esophageal Cancer in the National Clinical Database.

An observational study of the safety and efficacy of nivolumab as adjuvant treatment for esophageal cancer using the Comprehensive Registry of Esophageal Cancer in the National Clinical Database. - An observational study of the safety and efficacy of adjuvant nivolumab therapy for esophageal cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050925

Enrollment

1750

Registered

2023-04-25

Start date

2023-01-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Esophageal cancer or esophagogastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cases of squamous cell carcinoma or adenocarcinoma of the esophagus or esophagogastric junction following preoperative adjuvant therapy (chemotherapy or chemoradiotherapy) with R0 resection who first visited an authorized Institutes for Board Certified Esophageal Surgeons in 2023 and have not achieved a pathologic complete response to preoperative therapy.(Cases initially diagnosed in 2022 and operated on in 2023 will not be included, but cases initially diagnosed in 2023 and operated on in 2024 will be included.)

Exclusion criteria

Exclusion criteria: Cases of esophageal cancer other than squamous cell carcinoma or adenocarcinoma, have not been treated with neoadjuvant therapy, and that resulted in R1 or R2 resection.

Design outcomes

Primary

Measure	Time frame
1 Incidence rate of Grade 2 or higher adverse events of endocrine or judged to be immune-related among patients receiving adjuvant nivolumab therapy. 2 2-year recurrence-free survival rate: The recurrence-free survival rate at 2 years after the surgery, estimated by the Kaplan-Meier method, where the starting point is the date of surgery, the event is the cancer recurrence, and the censoring date is the last date when recurrence-free survival is confirmed.	—

Measure

Time frame

1 Incidence rate of Grade 2 or higher adverse events of endocrine or judged to be immune-related among patients receiving adjuvant nivolumab therapy. 2 2-year recurrence-free survival rate: The recurrence-free survival rate at 2 years after the surgery, estimated by the Kaplan-Meier method, where the starting point is the date of surgery, the event is the cancer recurrence, and the censoring date is the last date when recurrence-free survival is confirmed.

—

Countries

Japan

Contacts

Public ContactJun Kanamori

Cancer Institute Hospital of Japanese Foundation For Cancer Research Division of esophageal surgery

jun.kanamori@jfcr.or.jp0335200111

Outcome results