To hear about similar clinical trials, please enter your email below
Trial Title:
A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)
NCT ID:
NCT05652712
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab injection, recommended dose is 3 mg/kg, intravenous infusion every 2 weeks or
240 mg fixed dose, intravenous infusion every 3 weeks.
Other treatment options are individualized according to the diagnosis and treatment
experience of doctors in each center, diagnosis and treatment specifications and
individual conditions of patients.
Arm group label:
Immunotherapy Regimen
Summary:
Our project is going to clarify the efficacy and safety of Toripalimab in lung cancer in
the real world, and to evaluate the incidence of adverse events (AEs) of special interest
during Toripalimab immunotherapy.
Detailed description:
Tumor immunotherapy, as another important treatment after surgical treatment,
chemoradiotherapy and targeted therapy, has achieved great success and gradually become
one of the standard treatment methods for tumors. Toripalimab is the first Chinese PD-1
inhibitor approved for the treatment of nasopharyngeal carcinoma, malignant melanoma,
urothelial carcinoma, esophageal squamous cell carcinoma and non-small cell lung cancer.
It has been widely used in clinical practice. Several clinical studies have confirmed
that it is safe and effective. In recent years, several clinical studies have reported
that Toripalimab alone or in combination can improve the response rate of cancer
treatment and improve survival. The results of Toripalimab research are mainly derived
from rigorously designed randomized controlled trials (RCTs), and the efficacy and safety
in the real world still need to be further explored. Real world studies, based on a large
sample size, non-randomly select treatment measures according to the actual condition and
wishes of patients, and pay attention to meaningful outcome treatment, which is closer to
real clinical practice, without extrapolation difficulties, and has more clinical
practical value. Therefore, it is of great significance to carry out a real-world study
to investigate the differences in the efficacy and adverse reactions of Toripalimab
immunotherapy in Chinese lung cancer patients in order to better guide clinical practice,
which also provides research direction and data support for further prospective studies.
Criteria for eligibility:
Study pop:
Consecutive lung patients treated with Toripalimab
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18 years.
- Cytologically or histologically confirmed lung cancer.
- Complete clinical data.
- Indications for immunotherapy with Toripalimab.
Exclusion Criteria:
- Lack of patient key data.
- Refusal or uncooperation with the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Shandong First Medical University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiandong ZHANG
Phone:
+8653189269208
Email:
zhangjd165@sina.com
Start date:
January 1, 2019
Completion date:
June 1, 2023
Lead sponsor:
Agency:
Qianfoshan Hospital
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05652712
