Esophageal CancerNCT04966611
Anlotinib for Esophageal Cancer (AFEC)
An observational study of Esophageal Cancer, run by Anyang Tumor Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced esophageal cancer in the real world, and to summarize the treatment experience of a wide range of people. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Anlotinib
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 15 Jul 2024
- 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: Patients with advanced esophageal cancer
Who may be able to join
- Age: ≥ 18 years old, male or female;
- Patients with esophageal cancer were diagnosed;
- Patients assessed by doctors to benefit from single or combined treatment of arotinib;
- Patients volunteered to join the project.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang
Junsheng Mr Wang, doctor
About this study
Official title: A Real World Study on the Effect of Single or Combined Treatment of Anlotinib on Survival and Prognosis of Advanced Esophageal Cancer
The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced esophageal cancer in the real world, and to summarize the treatment experience of a wide range of people.
- Conditions
- Esophageal Cancer
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: From date of admission until the date of death from any cause, assessed up to 24 months
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anyang Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junsheng Wang, Anyang Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966611
- Sponsor's protocol ID
- AZLL022020001200116
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study on the Effect of Single or Combined Treatment of Anlotinib on Survival and Prognosis of Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04966611
- Acronym / sponsor ID
- AZLL022020001200116
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Anyang Tumor HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 19 Jul 2021 (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 purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced esophageal cancer in the real world, and to summarize the treatment experience of a wide range of people.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced esophageal cancer
Key inclusion criteria (4 listed)
- Age: ≥ 18 years old, male or female;
- Patients with esophageal cancer were diagnosed;
- Patients assessed by doctors to benefit from single or combined treatment of arotinib;
- Patients volunteered to join the project.
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 | – |
Primary outcome
OS
Time frame: From date of admission until the date of death from any cause, assessed up to 24 months
Overall Survival
1 secondary 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- 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.
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 Cancer, run by Anyang Tumor Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junsheng Mr Wang, doctor (0086-15950527350, junsheng20210616@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of admission until the date of death from any cause, 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 19 Jul 2021.