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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tislelizumab plus chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab, paclitaxel, Carboplatin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| intracranial 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 | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12months |
| objective response rate (ORR) (according to RECIST 1.1) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with any of the following criteria may not be included in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Likun Chen, Ph.D | Contact | 13798019964 | chenlk@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
ORR is defined as the proportion (%) of patients with complete or partial response of overall lesions
| 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. | 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 | 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 | 24months |
| Assessment of neurocognitive deterioration | Neurocognitive impairment according to Hopkins Verbal Learning Test-Revised(HVLT-R) | 24months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |