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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real-world Experience of Anti-PD-1 Immunotherapy Plus Chemotherapy as First-line Treatment for Patients With Advanced Oesophageal Squamous Cell Carcinoma in China(REACTION Trial).

Conditions
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Metastatic Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Anti-PD-1 Immune Checkpoint Inhibitors


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment.<br> | Drug: Anti-PD-1 Immune Checkpoint Inhibitors<br>* used as 1st line treatment for metastatic ESCC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 years |