An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03129256
- Lead Sponsor
- Changzhou Cancer Hospital of Soochow University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Pathologically confirmed Non-small cell lung cancer
- Patients with extracranial measurable lesions
- Patients with NSCLC failed for standard treatments
- Eastern Cooperative Oncology Group performance status score: 0~2 and life expectancy of more than 3 months
- Major organs functioning properly
- Compliance is good and agreed to cooperate with the survival of follow-up
- Informed consent
- Contraindications for investigational agents
- Patients with clinical symptoms of brain metastases or meningeal metastasis
- Tumor invade big vessels or close to big vessels
- Uncontrolled hypertension
- Abnormal coagulation (INR>1.5 or Prothrombin Time>ULN+4, or Activated Partial Thromboplastin Time>1.5 ULN), bleeding tendency or receiving coagulation therapy
- Hemoptysis, more than 2.5ml daily
- Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
- Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
- Received big surgery, had bone fracture or ulcer in 4 weeks.
- Urine protein≥++, or urine protein in 24 hours≥1.0g
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apatinib & S-1 Apatinib Mesylate tablet combined with S-1 capsules 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival(PFS) 2 years 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.
- Secondary Outcome Measures
Name Time Method Overall Survival(OS) 2 years Overall Survival is defined as the length of time from random assignment to death or to last contact.
Objective response rate(ORR) 2 years 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）
Disease Control Rate(DCR) 2 years Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.
Adverse Events(AEs) 2 years AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Trial Locations
- Locations (1)
Changzhou Cancer Hospital of Soochow University
🇨🇳Changzhou, Jiangsu, China