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

Recruiting

• Conditions: Esophageal Neoplasms
• Interventions: Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor

• Registration Number: NCT05349045
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27
• Study Start: 2022-05-05
• Primary Completion: 2024-05-05
• Study Completion: 2025-05-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor group	an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
OS	From date of admission until the date of death from any cause, assessed up to 24 months	Overall Survival

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China