Real-world Experience of ICIs Plus Chemotherapy for Advanced ESCC.
- Conditions
- Metastatic Esophageal Squamous Cell Carcinoma
- Interventions
- Drug: Anti-PD-1 Immune Checkpoint Inhibitors
- Registration Number
- NCT05142709
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
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 β₯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.
Patients who are prior exposure to immune-mediated therapy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment. Anti-PD-1 Immune Checkpoint Inhibitors -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (23)
Fujian Cancer Hospital & Fujian Medical University Cancer Hospital
π¨π³Fuzhou, Fujian, China
The 1st affiliated hospital of Xiamen University
π¨π³Xiamen, Fujian, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, Zhejiang, China
Jiangxi Cancer Hospital
π¨π³Nanchang, Jiangxi, China
The 2nd affiliated hospital of Bengbu medical University
π¨π³Bengbu, Anhui, China
The 2nd people's hospital of Anhui province
π¨π³Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
π¨π³Shenzhen, Guangdong, China
The 4th affiliated hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
Wuhan University Zhongnan hospital
π¨π³Wuhan, Hubei, China
Anyang cancer hospital
π¨π³Anyang, Henan, China
Zhongnan University Xiangya Hospital
π¨π³Changsha, Hunan, China
Huai'an first hospital
π¨π³Huai'an, Jiangsu, China
Nantong cancer hospital
π¨π³Nantong, Jiangsu, China
Jiangsu cancer Hosipital
π¨π³Nanjing, Jiangsu, China
Yancheng the 3rd hospital
π¨π³Yancheng, Jiangsu, China
The Northern Jiangsu People's Hospital
π¨π³Yangzhou, Jiangsu, China
The 1st affiliated hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
The 2nd affiliated hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
The First Affiliated Hospital of Air Force Medical University
π¨π³Xi'an, Shaanxi, China
Sichuan cancer hospital
π¨π³Chengdu, Sichuan, China
Fudan University Shanghai cancer center
π¨π³Shanghai, Shanghai, China
The 2nd affiliated hospital of Wenzhou medical university
π¨π³Wenzhou, Zhejiang, China