Metastatic Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
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
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.
Interventions
DRUGAnti-PD-1 Immune Checkpoint Inhibitors
used as 1st line treatment for metastatic ESCC.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS from start of 1st line treatment in metastatic ESCC | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS from start of 1st line treatment in metastatic ESCC | 18 months | 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. |
| the role of radiotherapy for patients treated with 1st immunotherapy. | 2 years | Compare the median OS and PFS and the rates between the group of patients treated with or without radiotherapy. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLvhua Wang, M.D.
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
PRINCIPAL_INVESTIGATORKuaile Zhao, M.D.
Fudan University
Outcome results
None listed