Metastatic Esophageal Squamous Cell CarcinomaNCT05142709
Real-world Experience of ICIs Plus Chemotherapy for Advanced ESCC.
An observational study of Metastatic Esophageal Squamous Cell Carcinoma, run by Fudan University at 23 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Esophageal Squamous Cell Carcinoma
- What is being tested?
- Anti-PD-1 Immune Checkpoint Inhibitors
- How many people
- 1,197 participants
- Where
- 23 sitesChina
- Study dates
- 31 Oct 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: More than 600 patients
Who may be able to join
- 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.
Who cannot join
- Patients who are prior exposure to immune-mediated therapy.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Anyang cancer hospital
Anyang, Henan
The 2nd affiliated hospital of Bengbu medical University
Bengbu, Anhui
Zhongnan University Xiangya Hospital
Changsha, Hunan
Sichuan cancer hospital
Chengdu, Sichuan
Fujian Cancer Hospital & Fujian Medical University Cancer Hospital
Fuzhou, Fujian
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
The 2nd people's hospital of Anhui province
Hefei, Anhui
Huai'an first hospital
Huai'an, Jiangsu
Jiangxi Cancer Hospital
Nanchang, Jiangxi
The 1st affiliated hospital of Nanchang University
Nanchang, Jiangxi
The 2nd affiliated hospital of Nanchang University
Nanchang, Jiangxi
Jiangsu cancer Hosipital
Nanjing, Jiangsu
Nantong cancer hospital
Nantong, Jiangsu
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, 200032
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
Shenzhen, Guangdong
The 4th affiliated hospital of Hebei Medical University
Shijiazhuang, Hebei
The 2nd affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang
Wuhan University Zhongnan hospital
Wuhan, Hubei
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi
The 1st affiliated hospital of Xiamen University
Xiamen, Fujian
Yancheng the 3rd hospital
Yancheng, Jiangsu
The Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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).
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.
Read the 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.
- Being tested
- Anti-PD-1 Immune Checkpoint Inhibitors
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 Immune Checkpoint InhibitorsDrug
used as 1st line treatment for metastatic ESCC.
| Study group | Role | What they receive |
|---|---|---|
| ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment. | Not described Receives: Drug: Anti-PD-1 Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start31 Oct 2021
- Primary completion30 Sep 2023
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
- Investigators
- Lvhua Wang, M.D., Principal investigator, Cancer Hospital Chinese Academy of Medical Science, Shenzhen CenterKuaile Zhao, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142709
- Sponsor's protocol ID
- ESO-Shanghai18
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2021
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Q, Chen J, Shen W, Ye J, Luo H, Zhang X, Liu W, Xu Y, Zhang Y, Liu A, Li X, Ge H, Wang Q, Luo H, Zhao L, Xie C, Lin Q, Xie C, Wang L, Zhao K. The role of thoracic radiotherapy in the setting of immunotherapy in polymetastatic esophageal squamous cell carcinoma: a multi-center cohort study. Ther Adv Med Oncol. 2026 Feb 12;18:17588359261419635. doi: 10.1177/17588359261419635. eCollection 2026.
PubMed 41696558
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05142709
- Acronym / sponsor ID
- ESO-Shanghai18
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,197 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Oct 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment. | – | Drug: Anti-PD-1 Immune Checkpoint Inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- More than 600 patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who are prior exposure to immune-mediated therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-PD-1 Immune Checkpoint Inhibitorsused as 1st line treatment for metastatic ESCC. | Drug | ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment. |
Primary outcome
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 secondary outcomes
PFS from start of 1st line treatment in metastatic ESCC
Time frame: 18 months
the role of radiotherapy for patients treated with 1st immunotherapy.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 41696558Liu Q, Chen J, Shen W, Ye J, Luo H, Zhang X, Liu W, Xu Y, Zhang Y, Liu A, Li X, Ge H, Wang Q, Luo H, Zhao L, Xie C, Lin Q, Xie C, Wang L, Zhao K. The role of thoracic radiotherapy in the setting of immunotherapy in polymetastatic esophageal squamous cell carcinoma: a multi-center cohort study. Ther Adv Med Oncol. 2026 Feb 12;18:17588359261419635. doi: 10.1177/17588359261419635. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lvhua Wang, M.D. principal investigator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Kuaile Zhao, M.D. principal investigator
Fudan University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Esophageal Squamous Cell Carcinoma, run by Fudan University at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS from start of 1st line treatment in metastatic ESCC (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.