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

Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05142709
• Other study ID #: ESO-Shanghai18
• Status: Active, not recruiting
• Start date: October 31, 2021
• Est. completion date: October 2024

Study information

• Verified date: April 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: October 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Metastatic Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Anti-PD-1 Immune Checkpoint Inhibitors
used as 1st line treatment for metastatic ESCC.

Locations

Country	Name	City	State
China	Anyang cancer hospital	Anyang	Henan
China	The 2nd affiliated hospital of Bengbu medical University	Bengbu	Anhui
China	Zhongnan University Xiangya Hospital	Changsha	Hunan
China	Sichuan cancer hospital	Chengdu	Sichuan
China	Fujian Cancer Hospital & Fujian Medical University Cancer Hospital	Fuzhou	Fujian
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	The 2nd people's hospital of Anhui province	Hefei	Anhui
China	Huai'an first hospital	Huai'an	Jiangsu
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The 1st affiliated hospital of Nanchang University	Nanchang	Jiangxi
China	The 2nd affiliated hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu cancer Hosipital	Nanjing	Jiangsu
China	Nantong cancer hospital	Nantong	Jiangsu
China	Fudan University Shanghai cancer center	Shanghai	Shanghai
China	Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center	Shenzhen	Guangdong
China	The 4th affiliated hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The 2nd affiliated hospital of Wenzhou medical university	Wenzhou	Zhejiang
China	Wuhan University Zhongnan hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Air Force Medical University	Xi'an	Shaanxi
China	The 1st affiliated hospital of Xiamen University	Xiamen	Fujian
China	Yancheng the 3rd hospital	Yancheng	Jiangsu
China	The Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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