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OpenTrials
Completed

NCT Number: NCT05142709

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The 2nd affiliated hospital of Bengbu medical University, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-PD-1 Immune Checkpoint Inhibitors

Drug

used as 1st line treatment for metastatic ESCC.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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).

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Dec 3, 2021
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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