Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Patients received four 21-day cycles of chemotherapy (decided by the researcher) combined with camrelizumab (200 mg in day 1), followed by maintenance with camrelizumab (200 mg in day 1, q3w), until one year or the disease progressed or unacceptable toxicity.
Nanfang Hospital, Southern Medical University
Guandong, Guangdong, China
RECRUITINGTwo-years disease free survival (2y-DFS)
DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. According to the K-M curve, the proportion of disease-free progression in 2 years.
Time frame: Up to approximately 2 years
Three-years disease free survival (3y-DFS)
According to the K-M curve, the proportion of disease-free progression in 3 years
Time frame: Up to approximately 3 years
Five-years disease free survival (5y-DFS)
According to the K-M curve, the proportion of disease-free progression in 5 years
Time frame: Up to approximately 5 years
Disease free survival (DFS)
DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Overall survival (OS)
Defined as the time from randomization to death from any cause.
Time frame: Up to approximately 5 years
Two-years overall survival(2y-OS)
According to the K-M curve, the proportion of OS in 2 years
Time frame: Up to approximately 2 years
Three-years overall survival(3y-OS)
According to the K-M curve, the proportion of OS in 3 years
Time frame: Up to approximately 3 years
Five-years overall survival(5y-OS)
According to the K-M curve, the proportion of OS in 5 years
Time frame: Up to approximately 5 years
Treatment-related adverse events(TRAE)
The incidence of TRAE and the incidence of level 3-4 TRAE according to CTCAE v5.0
Time frame: Up to approximately 1 year
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