NCT05142709

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,197

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 31, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 5, 2026

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

October 31, 2021

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • PFS from start of 1st line treatment in metastatic ESCC

    18 months

  • the role of radiotherapy for patients treated with 1st immunotherapy.

    2 years

Study Arms (1)

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

Drug: Anti-PD-1 Immune Checkpoint Inhibitors

Interventions

used as 1st line treatment for metastatic ESCC.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

More than 600 patients

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are prior exposure to immune-mediated therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

The 2nd affiliated hospital of Bengbu medical University

Bengbu, Anhui, China

Location

The 2nd people's hospital of Anhui province

Hefei, Anhui, China

Location

Fujian Cancer Hospital & Fujian Medical University Cancer Hospital

Fuzhou, Fujian, China

Location

The 1st affiliated hospital of Xiamen University

Xiamen, Fujian, China

Location

Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

Shenzhen, Guangdong, China

Location

The 4th affiliated hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Anyang cancer hospital

Anyang, Henan, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Wuhan University Zhongnan hospital

Wuhan, Hubei, China

Location

Zhongnan University Xiangya Hospital

Changsha, Hunan, China

Location

Huai'an first hospital

Huai'an, Jiangsu, China

Location

Jiangsu cancer Hosipital

Nanjing, Jiangsu, China

Location

Nantong cancer hospital

Nantong, Jiangsu, China

Location

Yancheng the 3rd hospital

Yancheng, Jiangsu, China

Location

The Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Location

The 1st affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The 2nd affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Location

Fudan University Shanghai cancer center

Shanghai, Shanghai Municipality, 200032, China

Location

Sichuan cancer hospital

Chengdu, Sichuan, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

The 2nd affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Lvhua Wang, M.D.

    Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

    PRINCIPAL INVESTIGATOR
  • Kuaile Zhao, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2021

First Posted

December 3, 2021

Study Start

October 31, 2021

Primary Completion

September 30, 2023

Study Completion

December 31, 2025

Last Updated

February 5, 2026

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations