A Phase 2 interventional study of Apatinib Mesylate tablet combined with S-1 capsules in Non-small Cell Lung Cancer, sponsored by Changzhou Cancer Hospital of Soochow University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by Changzhou Cancer Hospital of Soochow University · Phase 2, Interventional, and Treatment
This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.
Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 52 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Changzhou Cancer Hospital of Soochow University is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Apatinib Mesylate tablet combined with S-1 Capsules Apatinib Mesylate tablet 250mg once daily combined with S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules) 40mg\~60mg twice daily by mouth, d1-14, repeated every 3 weeks.
Drug: Apatinib Mesylate tablet combined with S-1 capsules
Oral use with low-dose Apatinib combined with S-1 until disease progression
Also known as: Ai Tan combined with S-1, Apatinib combined with S-1
Progression Free Survival(PFS)
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Time frame: 2 years
Overall Survival(OS)
Overall Survival is defined as the length of time from random assignment to death or to last contact.
Time frame: 2 years
Objective response rate(ORR)
Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）
Time frame: 2 years
Disease Control Rate(DCR)
Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.
Time frame: 2 years
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: 2 years
Plan to share: No
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Changzhou Cancer Hospital of Soochow University