Clinical trial NCT05142709: Real-world Experience of ICIs Plus Chemotherapy for Advanced ESCC.
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).
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Esophageal Squamous Cell Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: More than 600 patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: OS from start of 1st line treatment in metastatic ESCC
timeFrame: 2 years
Secondary outcomes:
measure: PFS from start of 1st line treatment in metastatic ESCC
timeFrame: 18 months
measure: the role of radiotherapy for patients treated with 1st immunotherapy.
timeFrame: 2 years
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The 2nd affiliated hospital of Bengbu medical University
state: Anhui
city: Hefei
country: China
facility: The 2nd people's hospital of Anhui province
state: Anhui
city: Fuzhou
country: China
facility: Fujian Cancer Hospital & Fujian Medical University Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: The 1st affiliated hospital of Xiamen University
state: Fujian
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
state: Guangdong
city: Shijiazhuang
country: China
facility: The 4th affiliated hospital of Hebei Medical University
state: Hebei
city: Anyang
country: China
facility: Anyang cancer hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan University Zhongnan hospital
state: Hubei
city: Changsha
country: China
facility: Zhongnan University Xiangya Hospital
state: Hunan
city: Huai'an
country: China
facility: Huai'an first hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu cancer Hosipital
state: Jiangsu
city: Nantong
country: China
facility: Nantong cancer hospital
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng the 3rd hospital
state: Jiangsu
city: Yangzhou
country: China
facility: The Northern Jiangsu People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The 1st affiliated hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The 2nd affiliated hospital of Nanchang University
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Medical University
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai cancer center
state: Shanghai
city: Chengdu
country: China
facility: Sichuan cancer hospital
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The 2nd affiliated hospital of Wenzhou medical university
state: Zhejiang
Study officials:
affiliation: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
name: Lvhua Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Kuaile Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: