AIPAAIAEC: Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Advanced Esophageal Cancer

Sponsor
The First Affiliated Hospital of Zhengzhou University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05349045
Collaborator
(none)
300
1
36
8.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
May 5, 2022
Anticipated Primary Completion Date :
May 5, 2024
Anticipated Study Completion Date :
May 5, 2025

Arms and Interventions

Arm Intervention/Treatment
an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor group

Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor
This is an observational study

Outcome Measures

Primary Outcome Measures

  1. PFS [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

Secondary Outcome Measures

  1. OS [From date of admission until the date of death from any cause, assessed up to 24 months]

    Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Esophageal cancer confirmed by histopathology or cytology

  2. Unresectable locally advanced/recurrent or metastatic esophageal cancer, or progression after neoadjuvant or adjuvant therapy

  3. Esophageal cancer patients who benefit from the use of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor evaluated by the researchers

  4. Patients who sign informed consent and voluntarily join the study

Exclusion Criteria:
  1. 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

  2. Patients who are undergoing treatment regimen of blind trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450000

Sponsors and Collaborators

  • The First Affiliated Hospital of Zhengzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Feng Wang, Chief physician, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier:
NCT05349045
Other Study ID Numbers:
  • 2022-KY-0179-002
First Posted:
Apr 27, 2022
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022