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

Fudan University1,197 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,197

Conditions

Metastatic Esophageal Squamous Cell Carcinoma

Interventions

Anti-PD-1 Immune Checkpoint InhibitorsDRUG

used as 1st line treatment for metastatic ESCC.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

The 2nd affiliated hospital of Bengbu medical University

Bengbu, Anhui, China

Outcomes

Primary Outcomes

OS from start of 1st line treatment in metastatic ESCC

Median OS and OS rate at 12 months, 18 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.

Time frame: 2 years

Secondary Outcomes

PFS from start of 1st line treatment in metastatic ESCC

Median PFS and PFS rate at 6 months, 12months and 18 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.

Time frame: 18 months

the role of radiotherapy for patients treated with 1st immunotherapy.

Compare the median OS and PFS and the rates between the group of patients treated with or without radiotherapy.

Time frame: 2 years

Data from ClinicalTrials.gov

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