NCT05894369

Brief Summary

To evaluate the predictive value and mechanism of inflammatory factors in peripheral blood on the prognosis of patients, and to explore the influencing factors of inflammation and tumor microenvironment on the efficacy of neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer. To explore the predictors of neoadjuvant therapy in patients with esophageal squamous cell carcinoma.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

2.2 years

First QC Date

May 26, 2023

Last Update Submit

November 20, 2024

Conditions

Esophageal Cancer

Keywords

neoadjuvant therapyimmunotherapyoverall survivalefficacysafety

Outcome Measures

Primary Outcomes (1)

  • Tumor diameter

    The tumor diameter will be measured to evaluate the therapeutic effect

    1 year

Secondary Outcomes (1)

  • Overall survival

    1 year

Study Arms (1)

Neoadjuvant chemotherapy combi

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with esophageal cancer

You may not qualify if:

  • The estimated survival time is less than 6 months; The first diagnosis had distant metastasis Suffering from malignant tumor or accompanying malignant disease in the past 5 years Pregnant or pregnant women. Vulnerable groups (those without informed ability, minors, vagrants, students and subordinates of researchers, employees of bidders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin hosptial of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

Yong Shun Chen

CONTACT

86+153 2712 2084yongshun2007@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 8, 2023

Study Start

May 4, 2023

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

CN(1)