A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer

Study Overview
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Brief Summary
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The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.

Official Title
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A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer

Conditions
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Esophageal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically diagnosed as esophageal squamous cell carcinoma KPS≥80 Adequate organ function No distant metastasis The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist Exclusion Criteria: incomplete medical record which affects statistical analysis have participated in previous interventional clinical trials other situations evaluated by investigators not meet the enrollment

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Objective Response Rate | Up to 24 weeks | 
| Safety as measured by number of participants with Grade 3 and 4 adverse events | Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0 | Up to 12 weeks | 
| Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses | The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses. | Up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response rate (pCR) | The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery | Three to five working days after surgery | 
| R0 resection rate | The R0 resection rate of esophagectomy | Three to five working days after surgery | 
| Overall survival | Overall survival rate | from the date of diagnosis to the date of death, assessed up to 100 months | 
| Event-free survival | EFS | from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months | 
| Major pathological response | ≤10% residual viable tumor follow NAIC | Three to five working days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, real-world study, immunotherapy, chemotherapy