Appatinib Combined With S-1 in the Treatment of Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04128800|
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Apatinib S-1||Phase 2|
Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. Small cell lung cancer accounts for about 15-20% of all lung cancer. Although the initial treatment is sensitive to radiotherapy and chemotherapy, patients with small cell lung cancer are prone to recurrence and metastasis in the early stage, and ultimately lead to death due to the lack of effective treatment after the disease progresses. Patients with relapsed small cell lung cancer had a poor prognosis; untreated patients had only two to three months of expected survival.Therefore, it is urgent to find a method to treat SCLC.
Two single-arm phase II clinical studies on small cell lung cancer have evaluated the efficacy and safety of bevacizumab combined with first-line chemotherapy for extensive SCLC. Two phase II single arm studies showed good efficacy and safety. Apatinib and bevacizumab are both antiangiogenic agents. S-1 is a new oral fluoropyrimidine anticancer agent, but S-1 has shown a high remission rate for metastatic NSCLC and relapsed NSCLC.
In view of the good efficacy and tolerability of oral chemotherapeutic agent S-1, and the lack of suitable targeted drugs after NGS treatment in relapsed S LCL patients after previous multithreaded treatment, this clinical trial is to study the efficacy and safety of combination of anti-angiogenesis drugs and S-1 in patients with failed or dangerous SCLC after second-line or more radiotherapy and chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-center, Single-arm Exploratory Clinical Study of Apatinib Mesylate Tablets Combined With S-1 in the Treatment of Second-line or More Advanced Small Cell Lung Cancer|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
|Experimental: Apatinib and S-1 group||
Drug: Apatinib S-1
apatinib 250 mg PO qd; S-1 40 mg PO in the morning and 60 mg PO in the evening; 14 days in combination, 21 days in a cycle.
Other Name: apatinib mesylate tablets
- Objective Response Rate(ORR) [ Time Frame: one year ]
- Disease Control Rate (DCR) [ Time Frame: one year ]
- Progression free survival (PFS) [ Time Frame: one year ]
- Overall survival (OS) [ Time Frame: one year ]
- Quality of life (QoL) [ Time Frame: one year ]
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): NCT04128800
|Contact: Ning bo Liu, MDemail@example.com|
|Contact: Ping Wang, MDfirstname.lastname@example.org|
|Tianjin Medical University Cancer Institute and Hospital||Recruiting|
|Tianjin, Tianjin, China, 300060|
|Contact: Ning bo Liu, MD 15822117210 email@example.com|
|Contact: Ping Wang, MD 18622221112 firstname.lastname@example.org|
|Principal Investigator:||Ning bo Liu, MD||Tianjin Medical University Cancer Institute & Hospital|