A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03787953|
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment|
|Advanced Solid Tumors||Drug: Anti-PD-1/PD-L1 antibodies|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors|
|Actual Study Start Date :||December 30, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
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
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.
- Progression-free survival (PFS) [ Time Frame: 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.
- Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy. [ Time Frame: up to 4 weeks after the last dose ]AEs/SAEs were evaluated using NCI-CTCAE v5.0
- Objective Response Rate (ORR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to 12 months ]OS was defined as the length of time from the administration of the first-dose until death from any cause.
- Biomarkers [ Time Frame: before the first dose ]Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787953
|Contact: Xiao Zhao, PhDemail@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, China, 100853|
|Contact: Xiao Zhao, PhD|
|Principal Investigator: Shunchang Jiao, PhD|
|Principal Investigator: Xiao Zhao, PhD|
|Principal Investigator:||Shunchang Jiao, PhD||Chinese PLA General Hospital|