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| Name | Class |
|---|---|
| LinkDoc Technology (Beijing) Co. Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-PD-1/PD-L1 antibodies | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-1/PD-L1 antibodies | Drug | 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. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI | before the first dose |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Zhao, PhD | Contact | +86-15210417668 | rws2018@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Shunchang Jiao, PhD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | 100853 | China |
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Biopsy specimen or blood specimen
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 |