Efficacy and Safety of Camrelizumab in Real-World Study
1 other identifier
observational
450
1 country
1
Brief Summary
This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
November 17, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedNovember 17, 2020
October 1, 2020
7 months
October 26, 2020
November 16, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
pCR
Neoadjuvant therapy population: pathological complete response rate (pCR).
From August 1, 2019 to June 31, 2021
R0 resection rate.
Neoadjuvant therapy population: R0 resection rate.
From August 1, 2019 to June 31, 2021
ORR
Advanced non-small cell lung cancer: objective response rate (ORR).
From August 1, 2019 to June 31, 2021
6-month PFS%
Advanced non-small cell lung cancer: 6-month progression-free survival rate (PFS%).
From August 1, 2019 to June 31, 2021
Secondary Outcomes (8)
MPR
From August 1, 2019 to June 31, 2021
operative rate
From August 1, 2019 to June 31, 2021
perioperative mortality
From August 1, 2019 to June 31, 2021
incidence of major postoperative complications
From August 1, 2019 to June 31, 2021
iORR
From August 1, 2019 to June 31, 2021
- +3 more secondary outcomes
Study Arms (1)
Camrelizumab-treated advanced NSCLC
Patients with advanced non-small cell lung cancer treated with camrelizumab. Dosage form, dosage, frequency and duration of camrelizumab is determined according to the investigator's actual clinical practice.
Interventions
Eligibility Criteria
Total 450 patients who have received camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.
You may qualify if:
- Age ≥18 years old;
- Histopathological diagnosed confirmed non-small cell lung cancer;
- Have received at least one camrelizumab injection between August 1, 2019 and December 31, 2020;
- Traceable cases.
You may not qualify if:
- Patients who have received other immunotherapy at the same time;
- Patients who were participating in other intervention studies;
- Patients with other malignant tumors;
- The researcher believes that the patient is not suitable to participate in this study with any other conditions .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wu Yilong, Doctor
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
November 17, 2020
Study Start
November 30, 2020
Primary Completion
June 30, 2021
Study Completion
December 30, 2021
Last Updated
November 17, 2020
Record last verified: 2020-10