Esophageal NeoplasmsNCT05303740
Anlotinib Retrospective Study for Esophageal Cancer
An observational study of Esophageal Neoplasms, run by Feng Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Anlotinib
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Esophageal cancer patients previously treated with anlotinib
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: 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.
- Conditions
- Esophageal Neoplasms
- Being tested
- Anlotinib
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Not described Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: 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
Overall Survival
Measured: From date of admission until the date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jan 2019
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303740
- Sponsor's protocol ID
- L2021-Y348-001
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05303740
- Acronym / sponsor ID
- L2021-Y348-001
- Conditions
- Esophageal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Feng WangUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | – | Drug: Anlotinib |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Esophageal cancer patients previously treated with anlotinib
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnlotinibThis is an observational study. | Drug | Anlotinib |
Primary outcome
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
1 secondary outcome
OS
Time frame: From date of admission until the date of death from any cause, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms, run by Feng Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.