Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC
NCT ID: NCT04663438
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2020-06-30
2021-05-30
Brief Summary
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Detailed Description
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Atezolizumab plus chemotherapy was approved by NMPA on Feb 13,2020,making Atezolizumab for 1L ES-SCLC in China.
Real world study can reflect the efficacy and safety of treatment in clinical practice.Based on the research of public database,the prospective cohort study had been reported,but the study based on Chinese patients still left weak point.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm A
200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w
Chemotherapy Drugs, Cancer
Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil
Arm B
100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w
Chemotherapy Drugs, Cancer
Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil
Interventions
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Chemotherapy Drugs, Cancer
Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil
Eligibility Criteria
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Inclusion Criteria
* No prior systemic treatment for ES-SCLC
* 18-80 years old, or more than 10 months of expected natural survival;
* Eastern Cooperative Oncology Group performance status of 0 or 1 or 2
* Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end organ function
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
* The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
Exclusion Criteria
Patients or family members cannot understand the conditions and goals of this study.
The subject has an estimated life expectancy of less than 10 months The subject is unable or unwilling to comply with the study requirements or follow-up schedule
18 Years
80 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
China-Japan Friendship Hospital
OTHER
Beijing Chest Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Li Zhang
Professor,Chief physician
Principal Investigators
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Li Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking union medical college hospital,China
Locations
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Peking union medical college hospital，
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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References
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Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
Other Identifiers
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ZS-2407
Identifier Type: -
Identifier Source: org_study_id