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

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: Metastatic Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Anti-PD-1 Immune Checkpoint Inhibitors

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

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

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	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	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.	Compare the median OS and PFS and the rates between the group of patients treated with or without radiotherapy.	2 years

Collaborators and Investigators

• 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

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: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Immune Checkpoint Inhibitors
• 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