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

Recruiting

• Conditions: Immunotherapy

• Registration Number: NCT05719324
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Study Timeline

• Study Start: 2022-02-08
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Status Verified: 2023-02
• Study First Posted: 2023-02-08
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS）	Up to 24 months.	PFS is defined as the time from initiation of checkpoint inhibitors until disease progression or death, whichever comes first.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 24 months.	OS is defined as the time from initiation of checkpoint inhibitors to death or last follow-up.

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China