Anlotinib Retrospective Study for Esophageal Cancer

March 27, 2022 updated by: Feng Wang

Efficacy and Safety of Anlotinib in the First-line or Second-line Treatment of Locally Advanced or Metastatic Esophageal Cancer in China, a Retrospective, Multicenter, Real-world Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Esophageal cancer patients previously treated with anlotinib

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anlotinib
Drug: Anlotinib
This is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of admission until the date of death from any cause, assessed up to 24 months
Overall Survival
From date of admission until the date of death from any cause, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Feng Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 27, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2021-Y348-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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