Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in A... | NCT05349045

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

NCT05349045

Sponsor

The First Affiliated Hospital of Zhengzhou University

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Esophageal Neoplasms

Interventions

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

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2022Estimated

Primary Completion Date

May 5, 2024Estimated

Completion Date

May 5, 2025Estimated

First Submitted Date

Apr 21, 2022

First Submission Date that Met QC Criteria

Apr 21, 2022

First Posted Date

Apr 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Feng Wang, Chief physician, The First Affiliated Hospital of Zhengzhou UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Zhengzhou UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Esophageal cancer confirmed by histopathology or cytology

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Zhengzhou University	Recruiting	Zhengzhou	Henan	450000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided