NCT06241066

Brief Summary

Retrospective analysis of the presence and maturity of tertiary lymphoid structures in pathological sections of patients with esophageal squamous cell carcinoma after surgical treatment. Pay attention to the overall survival and disease free survival of these esophageal squamous cell carcinoma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2014

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

December 1, 2023

Enrollment Period

9.8 years

First QC Date

January 25, 2024

Last Update Submit

February 2, 2024

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • OS

    Overall Survival

    The time from treatment to death or last follow-up, assessed up to 100 months.

  • DFS

    Disease-free Survival

    The time from treatment to the first recurrence or last follow-up, assessed up to 100 months.

Study Arms (4)

Surgery alone group

Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection without any prior treatment are included in this group. These patients had not been diagnosed with any other cancer. Finally, 96 patients were included.

Other: no-Intervention

Neoadjuvant chemotherapy group

Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 89 patients were included.

Other: no-Intervention

Neoadjuvant chemotherapy combined with immunotherapy group

Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with immunotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 81 patients were included.

Other: no-Intervention

Neoadjuvant chemotherapy combined with radiotherapy group

Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with radiotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 93 patients were included.

Other: no-Intervention

Interventions

no-InterventionOTHER

no-Intervention

Neoadjuvant chemotherapy combined with immunotherapy groupNeoadjuvant chemotherapy combined with radiotherapy groupNeoadjuvant chemotherapy groupSurgery alone group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients pathologically confirmed esophageal squamous cell carcinoma(ESCC) who underwent complete surgical resection at Tianjin Medical University Cancer Hospital between 2014 and 2021

You may qualify if:

  • \. Pathologically diagnosed as esophageal squamous cell carcinoma; 2. Surgery for esophageal cancer; 3. Complete medical records;

You may not qualify if:

  • Patients with a previous history of malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

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

  • Wencheng Zhang, M.D.

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 5, 2024

Study Start

January 1, 2014

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)