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

NCT ID: NCT05142709

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Metastatic Esophageal Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment.

Anti-PD-1 Immune Checkpoint Inhibitors

Intervention Type DRUG

used as 1st line treatment for metastatic ESCC.

Interventions

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Anti-PD-1 Immune Checkpoint Inhibitors

used as 1st line treatment for metastatic ESCC.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Kuai Le Zhao, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lvhua Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Kuaile Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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The 2nd affiliated hospital of Bengbu medical University

Bengbu, Anhui, China

Site Status

The 2nd people's hospital of Anhui province

Hefei, Anhui, China

Site Status

Fujian Cancer Hospital & Fujian Medical University Cancer Hospital

Fuzhou, Fujian, China

Site Status

The 1st affiliated hospital of Xiamen University

Xiamen, Fujian, China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

Shenzhen, Guangdong, China

Site Status

The 4th affiliated hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Anyang cancer hospital

Anyang, Henan, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Wuhan University Zhongnan hospital

Wuhan, Hubei, China

Site Status

Zhongnan University Xiangya Hospital

Changsha, Hunan, China

Site Status

Huai'an first hospital

Huai'an, Jiangsu, China

Site Status

Jiangsu cancer Hosipital

Nanjing, Jiangsu, China

Site Status

Nantong cancer hospital

Nantong, Jiangsu, China

Site Status

Yancheng the 3rd hospital

Yancheng, Jiangsu, China

Site Status

The Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Site Status

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Site Status

The 1st affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

The 2nd affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

The First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Site Status

Fudan University Shanghai cancer center

Shanghai, Shanghai Municipality, China

Site Status

Sichuan cancer hospital

Chengdu, Sichuan, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

The 2nd affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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ESO-Shanghai18

Identifier Type: -

Identifier Source: org_study_id

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