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

Esophageal Neoplasms Clinical Trial

— AIPAAIAEC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349045
• Other study ID #: 2022-KY-0179-002
• Status: Recruiting
• Start date: May 5, 2022
• Est. completion date: May 5, 2025

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 5, 2025
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	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	OS	Overall Survival	From date of admission until the date of death from any cause, assessed up to 24 months