Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
200 mg Toripalimab intravenously every 3 weeks 3 doses of Toripalimab before operation 14 doses of Toripalimab 30 days after operation
the does of radiation will be 40-45Gy. The day of the first dose of Toripalimab and the first day of radiation must be the same day.
The operable patients will accept radical operated in 28-42 days after the third dose of Toripalimab
People's hospital of northern jiangsu
Yangzhou, Jiangsu, China
RECRUITINGMajor pathologic response rates
Major pathological response rates assessed by independent center pathology
Time frame: 42months
Event-free survival
The time from the beginning of enrollment to the occurrence of any events, including death, disease progression, change of chemotherapy regimen, change of chemotherapy, addition of other treatments, the occurrence of fatal or intolerant side effects and other events
Time frame: 42months
Overall survival
Kaplan-Meier median estimates and curves will be used to describe OS survival functions
Time frame: 42 months
Pathologic complete response (pCR) rates
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review.
Time frame: 42months
Disease-free survival
Some time until the tumor recurs or die for various reasons
Time frame: 42 months
Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment. AEs/SAEs were evaluated using NCI-CTCAE v5.0
Time frame: 42 months
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