A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 27, 2018
CompletedStudy Start
First participant enrolled
December 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedMay 16, 2019
May 1, 2019
9 months
December 20, 2018
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Objective Response Rate (ORR)
6 months
Disease Control Rate (DCR)
6 months
Overall survival (OS)
up to 12 months
Other Outcomes (1)
Biomarkers
before the first dose
Study Arms (1)
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
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.
Eligibility Criteria
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
You may qualify if:
- Pathologically or cytologically confirmed advanced solid tumors;
- Received anti-PD-1/PD-L1 antibody therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, 100853, China
Biospecimen
Biopsy specimen or blood specimen
Study Officials
- PRINCIPAL INVESTIGATOR
Shunchang Jiao, PhD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 20, 2018
First Posted
December 27, 2018
Study Start
December 30, 2018
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
May 16, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share