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

NCT05349045 | Unknown DMC

• 1 other identifier: 2022-KY-0179-002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• OS

  From date of admission until the date of death from any cause, assessed up to 24 months

Study Arms (1)

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

Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor

Interventions

an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor DRUG

This is an observational study

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Esophageal cancer confirmed by histopathology or cytology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: May 5, 2022
• Primary Completion: May 5, 2024
• Study Completion: May 5, 2025
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)