Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study

NCT ID: NCT05719324

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-08

Study Completion Date

2024-03-31

Brief Summary

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This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.

Detailed Description

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The clinical data of patients with unresectable solid tumors were collected retrospectively, who received two or more cycles of checkpoint inhibitor therapy. The progression-free survival (PFS), overall survival (OS) and related adverse reactions of the patients were followed up. To screen prognostic factors, develop predictive models and visualize them as nomograms.

Conditions

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Immunotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old and gender is not limited.
* Patients with unresectable solid tumors confirmed by pathology or histology.
* Patients received checkpoint inhibitor therapy for 2 cycles or more.

Exclusion Criteria

* Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
* Pre-existing thyroid dysfunction that cannot be maintained within the normal range even with medical treatment.
* Pregnant or breastfeeding women.
* Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
* The investigator judges that other conditions are not suitable for inclusion in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lingxiang Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lingxiang Liu, MD

Role: CONTACT

(+86) 13851892074

Facility Contacts

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Lingxiang Liu, MD

Role: primary

(+86) 13851892074

Other Identifiers

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2022-SR-219

Identifier Type: -

Identifier Source: org_study_id

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