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

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.

Study Overview

• Status: Recruiting
• Conditions: Immunotherapy

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Lingxiang Liu, MD; Phone Number: (+86) 13851892074; Email: llxlau@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Contact: Lingxiang Liu, MD; Phone Number: (+86) 13851892074; Email: llxlau@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable solid tumors confirmed by histopathology or cytology, and continuously treated with checkpoint inhibitor based treatment for 2 cycles or more.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as the percentage of patients achieving complete response and partial response.	Up to 24 months.
Disease Control Rate (DCR)	DCR is defined as the percentage of patients achieving complete response, partial response and stable disease.	Up to 24 months.
Adverse events (AE)	AE includes abnormalities in clinical symptoms, vital signs and laboratory tests.	Up to 24 months.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Lingxiang Liu, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Checkpoint inhibitor; Immunotherapy; Solid tumor; Predictor
• Other Study ID Numbers: 2022-SR-219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No