Real-world Experience of ICIs Plus Chemotherapy for Advanced ESCC.

Fudan University

Status: Completed

Conditions: Metastatic Esophageal Squamous Cell Carcinoma

Treatments: Drug: Anti-PD-1 Immune Checkpoint Inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT05142709

ESO-Shanghai18

Details and patient eligibility

About

This study is a multi-center, non-interventional study. Clinicopathologic, treatment , outcome and efficacy data will be collected from medical records in metastatic esophageal squamous cell carcinoma (ESCC) patients.

Full description

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected in metastatic esophageal squamous cell carcinoma (ESCC) patients who were treated with ICIs as 1st line treatment at approximately 26 institutions. The patients should have received at least 1 cycle of anti-PD-1 immunotherapy with or without radiotherapy. Based on these data, overall survival (OS), progression free survival (PFS) from start of 1st line treatment and the role and efficacy of radiotherapy for these patients will be assessed.

Enrollment: 1,197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age > 18, had an Eastern Cooperative Oncology Group performance status score of 0-3; Patients had unresectable or recurrent disease that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease; Patients had received no previous systemic therapy (patients who had progressed ≥6 months after [neo]adjuvant therapy or definitive chemoradiation were eligible); Patients accepted at least one cycle of anti-PD-1 immunotherapy as 1st line treatment, combined chemotherapy was allowed.

Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.

Exclusion criteria

Patients who are prior exposure to immune-mediated therapy.

Trial design

1,197 participants in 1 patient group

ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment.

Treatment:

Drug: Anti-PD-1 Immune Checkpoint Inhibitors