Risk of Esophageal Cancer Returning After Immunotherapy, Chemotherapy, and Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute

About this trial

This observational study aims to understand the risk of cancer returning after surgery in people with esophageal squamous cell carcinoma, a type of cancer of the food pipe. It focuses on people who received immunotherapy and chemotherapy before surgery.

Researchers will review existing medical records, scans, reports on tissue removed during surgery, and follow-up information. They will examine when and where cancer returns and which patient characteristics, treatment details, scan findings, and tissue findings are associated with its return.

All treatment and tests were part of routine care. The study does not assign treatment or require additional scans, tissue collection, or follow-up visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older at the time of surgery.

Disqualifiers

Histology other than esophageal squamous cell carcinoma, R1 or R2 resection.

Trial population

The source population comprises adults who underwent esophagectomy for esophageal squamous cell carcinoma at the study institution between August 1, 2020, and October 31, 2025. Patients will be identified through institutional medical records, imaging archives, surgical and pathology registries, and existing follow-up records. All patients within this surgical window who received neoadjuvant immunochemotherapy and meet the eligibility criteria will be included. No random sampling will be performed. Documented postoperative outcomes will be reviewed through December 1, 2025.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: ESCC After Neoadjuvant Immunochemotherapy and Surgery

Trial outcomes

Primary outcomes

1

Recurrence-Free Survival

Time, in months, from surgery to the first documented local, regional, or distant recurrence, determined using imaging, pathology, or documented clinical assessment. Participants without recurrence will be censored at their last disease assessment. Death without documented recurrence is not an RFS event; these participants will be censored at their last disease assessment before death. RFS probabilities at 12 and 24 months after surgery will be estimated using the Kaplan-Meier method.

Time frame
From surgery through December 1, 2025, up to 64 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

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