Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03983759|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer Extensive Disease Adoptive Cellular Immunotherapy Chemotherapy Maintenance||Drug: sintilimab maintenance||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy|
|Estimated Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: treatment group
phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events.
the dose of sintilimab is fixed dose of 200mg every three weeks
Drug: sintilimab maintenance
the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.
- median survival time [ Time Frame: two years. ]the period from the day of enrollment to the date of death
- progression-free survival [ Time Frame: six months ]the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first.
- objective response rate of sintilimab [ Time Frame: six month ]from the date of first dose of sintilimab to the date of confirmed progression following
- adverse events rate of sintilimab [ Time Frame: one year ]the rate of adverse events during the maintenance therapy of sintilimab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983759
|Contact: Quanli Gao, Dr.||+email@example.com|
|Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital|
|Zhengzhou, Henan, China, 450008|
|Principal Investigator:||Jing Ding, Master||Henan Cancer Hospital|