Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Outcome Measures
Primary Outcome Measures
- 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
- Overall survival (OS) [Up to 24 months.]
OS is defined as the time from initiation of checkpoint inhibitors to death or last follow-up.
Other Outcome Measures
- Objective response rate (ORR) [Up to 24 months.]
ORR is defined as the percentage of patients achieving complete response and partial response.
- Disease Control Rate (DCR) [Up to 24 months.]
DCR is defined as the percentage of patients achieving complete response, partial response and stable disease.
- Adverse events (AE) [Up to 24 months.]
AE includes abnormalities in clinical symptoms, vital signs and laboratory tests.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
Investigators
- Principal Investigator: Lingxiang Liu, MD, The First Affiliated Hospital with Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-SR-219