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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.
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.
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| 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. |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable solid tumors confirmed by histopathology or cytology, and continuously treated with checkpoint inhibitor based treatment for 2 cycles or more.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingxiang Liu, MD | Contact | (+86) 13851892074 | llxlau@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lingxiang Liu, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Up to 24 months. |
| Adverse events (AE) | AE includes abnormalities in clinical symptoms, vital signs and laboratory tests. | Up to 24 months. |