Advanced Solid Tumors
Conditions
Keywords
anti-PD-1/PD-L1 antibodies, Efficacy, Safety, Real world study
Brief summary
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
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.
Interventions
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.
Sponsors
LinkDoc Technology (Beijing) Co. Ltd.
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically or cytologically confirmed advanced solid tumors; * Received anti-PD-1/PD-L1 antibody therapy.
Exclusion criteria
* No specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy. | up to 4 weeks after the last dose | AEs/SAEs were evaluated using NCI-CTCAE v5.0 |
| Objective Response Rate (ORR) | 6 months | 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). |
| Disease Control Rate (DCR) | 6 months | 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). |
| Overall survival (OS) | up to 12 months | OS was defined as the length of time from the administration of the first-dose until death from any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | before the first dose | Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI |
Countries
China
Contacts
Primary ContactXiao Zhao, PhD
Outcome results
None listed