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

February 4, 2026 updated by: Kuai Le Zhao, MD, Fudan University

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • The 2nd affiliated hospital of Bengbu medical University
      • Hefei, Anhui, China
        • The 2nd people's hospital of Anhui province
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Cancer Hospital & Fujian Medical University Cancer Hospital
      • Xiamen, Fujian, China
        • The 1st affiliated hospital of Xiamen University
    • Guangdong
      • Shenzhen, Guangdong, China
        • Cancer Hospital Chinese Academy of Medical Sciences，Shenzhen center
    • Hebei
      • Shijiazhuang, Hebei, China
        • The 4th affiliated hospital of Hebei Medical University
    • Henan
      • Anyang, Henan, China
        • Anyang Cancer Hospital
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan University Zhongnan Hospital
    • Hunan
      • Changsha, Hunan, China
        • Zhongnan University Xiangya Hospital
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Huai'an first hospital
      • Nanjing, Jiangsu, China
        • JiangSu Cancer Hosipital
      • Nantong, Jiangsu, China
        • Nantong Cancer Hospital
      • Yancheng, Jiangsu, China
        • Yancheng the 3rd hospital
      • Yangzhou, Jiangsu, China
        • The Northern Jiangsu People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Cancer Hospital
      • Nanchang, Jiangxi, China
        • The 1st Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China
        • The 2nd affiliated hospital of Nanchang University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Air Force Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Cancer hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer Hospital
      • Wenzhou, Zhejiang, China
        • The 2nd Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

More than 600 patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment.
Drug: Anti-PD-1 Immune Checkpoint Inhibitors
used as 1st line treatment for metastatic ESCC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS from start of 1st line treatment in metastatic ESCC
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS from start of 1st line treatment in metastatic ESCC
Time Frame: 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.
18 months
the role of radiotherapy for patients treated with 1st immunotherapy.
Time Frame: 2 years
Compare the median OS and PFS and the rates between the group of patients treated with or without radiotherapy.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Kuaile Zhao, M.D., Fudan University
  • Principal Investigator: Lvhua Wang, M.D., Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

October 31, 2021

First Submitted That Met QC Criteria

November 21, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO-Shanghai18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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