A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors

Study Overview
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Brief Summary
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The study was designed to analyze the efficacy and safety of anti-PD-1/PD-L1 antibodies for the treatment of advanced solid tumors.

Detailed Description
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The study is a real-world study and the case records of patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy will be collected in this study. The medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to analyze the effectivity and safety of anti-PD-1/PD-L1 antibodies and explore the prognosis-relevant factors of advanced solid tumors.

Official Title
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A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: Anti-PD-1/PD-L1 antibodies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically or cytologically confirmed advanced solid tumors; Received anti-PD-1/PD-L1 antibody therapy. Exclusion Criteria: No specific exclusion criteria in this real world study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anti-PD-1/PD-L1 antibodies<br>Patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy | Drug: Anti-PD-1/PD-L1 antibodies<br>* The study is a real-world study. According to the actual medical history of patients, the usage of anti-PD-1/PD-L1 antibodies was collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy. | AEs/SAEs were evaluated using NCI-CTCAE v5.0 | up to 4 weeks after the last dose | 
| Objective Response Rate (ORR) | ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST). | 6 months | 
| Disease Control Rate (DCR) | DCR was defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST). | 6 months | 
| Overall survival (OS) | OS was defined as the length of time from the administration of the first-dose until death from any cause. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-PD-1/PD-L1 antibodies, Efficacy, Safety, Real world study