Esophageal NeoplasmsAIPAAIAECNCT05349045
Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Advanced Esophageal Cancer
An observational study of Esophageal Neoplasms, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The combination of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor has shown efficacy in many cancers.The purpose of this study is to confirm that the combination of these two drugs can benefit patients with advanced esophageal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2022to 5 May 2025
- 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 confirmed by histopathology or cytology
Who may be able to join
- Esophageal cancer confirmed by histopathology or cytology
- Unresectable locally advanced/recurrent or metastatic esophageal cancer, or progression after neoadjuvant or adjuvant therapy
- Esophageal cancer patients who benefit from the use of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor evaluated by the researchers
- Patients who sign informed consent and voluntarily join the study
Who cannot join
- Patients who are recommended not using an anti-PD-1/PD-L1 antibody or an angiogenesis inhibitor in the instructions, or other patients who are judged by the investigators to be unsuitable in the study
- Patients who are undergoing treatment regimen of blind trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Feng Mr Wang, doctor, 13938244776, fengw010@163.com
About this study
Official title: Containing Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Anti-tumor Treatment of Chinese Patients With Unresectable Locally Advanced / Recurrent or Metastatic Esophageal Cancer: a Real World Study
The combination of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor has shown efficacy in many cancers.The purpose of this study is to confirm that the combination of these two drugs can benefit patients with advanced esophageal cancer.
- Conditions
- Esophageal Neoplasms
- Being tested
- an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitorDrug
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor group | Not described Receives: Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor |
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 posted27 Apr 2022
- Study start5 May 2022 (estimated)
- Primary completion5 May 2024 (estimated)
- Study completion5 May 2025 (estimated)
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.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349045
- Sponsor's protocol ID
- 2022-KY-0179-002
- Acronym
- AIPAAIAEC
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Containing Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Anti-tumor Treatment of Chinese Patients With Unresectable Locally Advanced / Recurrent or Metastatic Esophageal Cancer: a Real World Study
- ClinicalTrials.gov ID
- NCT05349045
- Acronym / sponsor ID
- AIPAAIAEC / 2022-KY-0179-002
- Conditions
- Esophageal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (estimated)
- Primary completion
- 5 May 2024 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 27 Apr 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 combination of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor has shown efficacy in many cancers.The purpose of this study is to confirm that the combination of these two drugs can benefit patients with advanced esophageal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor group | – | Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Esophageal cancer confirmed by histopathology or cytology
Key inclusion criteria (4 listed)
- Esophageal cancer confirmed by histopathology or cytology
- Unresectable locally advanced/recurrent or metastatic esophageal cancer, or progression after neoadjuvant or adjuvant therapy
- Esophageal cancer patients who benefit from the use of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor evaluated by the researchers
- Patients who sign informed consent and voluntarily join the study
Key exclusion criteria (2 listed)
- Patients who are recommended not using an anti-PD-1/PD-L1 antibody or an angiogenesis inhibitor in the instructions, or other patients who are judged by the investigators to be unsuitable in the study
- Patients who are undergoing treatment regimen of blind trial
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 |
|---|---|---|
| an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitorThis is an observational study | Drug | an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor group |
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
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 The First Affiliated Hospital of Zhengzhou University 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 2 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 27 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 27 Apr 2022.