NCT05303740

Brief Summary

The efficacy of anlotinib in the treatment of esophageal cancer has been confirmed. The purpose of this study was to retrospectively observe the efficacy and safety of anlotinib in the first and second line of advanced esophageal cancer in the real world.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.2 years

First QC Date

March 14, 2022

Last Update Submit

March 27, 2022

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression Free Survival

    From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (1)

  • OS

    From date of admission until the date of death from any cause, assessed up to 24 months

Study Arms (1)

Anlotinib

Drug: Anlotinib

Interventions

AnlotinibDRUG

This is an observational study.

Anlotinib

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Esophageal cancer patients previously treated with anlotinib

You may qualify if:

  • Esophageal cancer diagnosed pathologically or clinically
  • Patients who use anlotinib alone, or combined with chemoradiotherapy, or plus PD-1 inhibitors in first-line or second-line treatment

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

anlotinib

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 INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 31, 2022

Study Start

January 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)