NCT06828718

Brief Summary

The prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma were compared with different neoadjuvant therapy modes in multi-cancer centers in China

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress95%
Jan 2015Dec 2026

Study Start

First participant enrolled

January 1, 2015

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

11 years

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

Esophageal Carcinoma

Keywords

Esophageal CarcinomaNeoadjuvant therapyPrognosis

Outcome Measures

Primary Outcomes (2)

  • Comparison of pathological complete response rate (pCR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    Pathological complete response (pCR) is defined as the absence of residual tumor cells after evaluation of removed tumor tissue and regional lymph nodes.

    2015.1.1-2023.12.31

  • Comparison of major pathological response (MPR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    Major pathological response (MPR) is defined as a tumor that has significantly shrunk or decreased in the pathological evaluation, but still has a small number of residual tumor cells.

    2015.1.1-2023.12.31

Secondary Outcomes (2)

  • Comparison of the overall survival (OS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    2015.1.1-2025.12.31

  • Comparison of the disease-free survival (DFS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    2015.1.1-2025.12.31

Other Outcomes (1)

  • Comparison of incidence of treatment-related adverse evants after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    2015.1.1-2025.12.31

Study Arms (4)

Neoadjuvant chemoradiotherapy

Patients with locally advanced esophageal squamous cell carcinoma received neoadjuvant chemoradiotherapy and then underwent surgical resection

Neoadjuvant chemotherapy

Patients with locally advanced esophageal squamous cell carcinoma received neoadjuvant chemotherapy followed by surgical resection

Neoadjuvant chemotherapy combined with immunotherapy

Patients with locally advanced esophageal squamous cell carcinoma underwent surgical resection after neoadjuvant chemotherapy combined with immunotherapy

Neoadjuvant chemoradiotherapy combined with immunotherapy

Patients with locally advanced esophageal squamous cell carcinoma underwent surgical resection after neoadjuvant chemoradiotherapy combined with immunotherapy

Eligibility Criteria

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

we compared the prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma who received different neoadjuvant therapy before surgery, including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant chemotherapy combined with immunotherapy, and neoadjuvant chemoradiotherapy combined with immunotherapy in several cancer centers in China.

You may qualify if:

  • Age ≥18 years, male or female;
  • KPS score (KPS) ≥70;
  • Esophageal squamous cell carcinoma confirmed by histopathology;
  • Clinical stage cT1b-4aN+M0,T3-4aN0M0;
  • Surgical resection was performed after 2\~4 cycles of neoadjuvant therapy.
  • Expected survival \> 6 months.

You may not qualify if:

  • Have a history of other malignancies (except for cancer in situ that has been cured and other malignancies that have been cured for more than 5 years);
  • There are contraindications of immunotherapy or chemoradiotherapy;
  • Inability to tolerate or refuse surgery;
  • Distant metastasis has occurred;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

January 1, 2015

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations

CN(1)