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

Immunotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719324
• Other study ID #: 2022-SR-219
• Status: Recruiting
• Start date: February 8, 2022
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Lingxiang Liu, MD
• Phone: (+86) 13851892074
• Email: llxlau[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immunotherapy

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective response rate (ORR)	ORR is defined as the percentage of patients achieving complete response and partial response.	Up to 24 months.
Other	Disease Control Rate (DCR)	DCR is defined as the percentage of patients achieving complete response, partial response and stable disease.	Up to 24 months.
Other	Adverse events (AE)	AE includes abnormalities in clinical symptoms, vital signs and laboratory tests.	Up to 24 months.
Primary	Progression-free survival (PFS)	PFS is defined as the time from initiation of checkpoint inhibitors until disease progression or death, whichever comes first.	Up to 24 months.
Secondary	Overall survival (OS)	OS is defined as the time from initiation of checkpoint inhibitors to death or last follow-up.	Up to 24 months.