A Real-world Study of the Efficacy and Safety of ICIs as... | NCT05862259

Studies
A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies

NCT05862259

Sponsor

Xinqiao Hospital of Chongqing

Status

Recruiting

Last Update Posted

Jul 14, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Malignant Tumor
Immunotherapy
Artificial Intelligence

Interventions

Not provided

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2023Actual

Primary Completion Date

Aug 10, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 8, 2023

First Submission Date that Met QC Criteria

May 8, 2023

First Posted Date

May 17, 2023Actual

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

Jul 11, 2025

Last Update Posted Date

Jul 14, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianguo Sun, Deputy director of oncology department，clinical professor, Xinqiao Hospital of ChongqingPrincipal Investigator

Lead Sponsor

Xinqiao Hospital of ChongqingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

In this study, we collected the data of immunohistochemistry, gene detection, image, OS, PFS, Orr, and so on. Secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy

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

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival	The time between randomization and the first occurrence of disease progression or death from any cause	six months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Time from randomization to death from any cause	two years
Objective response rate	Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements

Other Outcomes

Measure	Description	Time Frame
Indicators of cardiac injury	Including but not limited to troponin, BNP and cardiac magnetic resonance imaging	two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.
the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology.
the stage IV according to the eighth edition of IASLC.
PS 0-2, the expected survival > 3 months.
the age of 18-75 years.
no contraindication to treatment with immune checkpoint inhibitors.

Exclusion Criteria:

the patients' compliance was poor, which violated the rules of the trial;
the patients with severe dysfunction of vital organs (heart, liver and kidney) ;
the patients with other malignant tumors;
the researchers considered that the patients should not participate in other conditions of the trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

receiving immunotherapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the second affiliated hospital of Army medical university	Recruiting	Chongqing	Chongqing Municipality	40037	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided