This study is a prospective, single-arm, phase II clinical study to evaluate the efficacy and safety of Tislelizumab Plus Chemotherapy in patients with squamous NSCLC with brain metastases who had not previously received systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Tislelizumab, 200mg administered intravenously (IV) on Day 1 of each 21-day cycle paclitaxel 175 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4-6cycle Carboplatin AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4-6 cycle
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGintracranial progression-free survival (iPFS) after treatment with tislelizumab plus chemotherapy in patients with asymptomatic brain metastases or stable symptoms after stereotactic radiotherapy (according to RECIST 1.1)
Intracranial Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of intracranial disease progression or death, whichever occurs first
Time frame: 12months
intracranial objective response rate (iORR) (according to RECIST 1.1)
iORR is defined as the proportion (%) of patients with complete or partial response of intracranial lesions
Time frame: 12months
objective response rate (ORR) (according to RECIST 1.1)
ORR is defined as the proportion (%) of patients with complete or partial response of overall lesions
Time frame: 12months
progression-free survival (PFS) (according to RECIST 1.1)
Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of overall disease progression or death, whichever occurs first.
Time frame: 12months
overall survival (OS) (according to RECIST 1.1)
OS is defined as the time from the starting date of study drug to the date of death due to any cause
Time frame: 24months
Safety of treatment was assessed using NCI-CTCAEv5 version
TEAEs graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Time frame: 24months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Assessment of neurocognitive deterioration
Neurocognitive impairment according to Hopkins Verbal Learning Test-Revised(HVLT-R)
Time frame: 24months