Real World Study of Four PD-1 Agents in China
Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China
1 other identifier
observational
500
1 country
1
Brief Summary
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 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
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMay 29, 2019
May 1, 2019
3 years
May 22, 2019
May 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.
1 year
Secondary Outcomes (1)
Number of Participants Experiencing Adverse Events (AEs)
1 year
Other Outcomes (1)
PFS
2 years
Study Arms (4)
nivolumab
Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.
pembrolizumab
Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.
toripalimab
Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.
sintilimab
Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.
Interventions
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
Eligibility Criteria
Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)
You may qualify if:
- Patients with lung cancer, liver cancer and other solid cancers
- Histologically or cytologically confirmed diagnosis cancer treated with PD-1 agents
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1 Adequate organ function
You may not qualify if:
- patients treated with PD-1 agents less than 2 terms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaochun Zhang, Dr
The Affiliated Hospital of Qingdao University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cancer Precision Medical Center
Study Record Dates
First Submitted
May 22, 2019
First Posted
May 29, 2019
Study Start
June 1, 2018
Primary Completion
June 1, 2021
Study Completion
June 1, 2023
Last Updated
May 29, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
IPD only shared in the study group