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Trial Title:
Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study
NCT ID:
NCT05719324
Condition:
Immunotherapy
Conditions: Keywords:
Immunotherapy
Checkpoint inhibitor
Solid tumor
Predictor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
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:
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.
Criteria for eligibility:
Study pop:
Patients with unresectable solid tumors confirmed by histopathology or cytology, and
continuously treated with checkpoint inhibitor based treatment for 2 cycles or more.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital with Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Lingxiang Liu, MD
Phone:
(+86) 13851892074
Email:
llxlau@163.com
Start date:
February 8, 2022
Completion date:
March 2024
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05719324
