Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB&IV patients. It is a randomized controlled clinical trial.

Detailed Description
-----------------
Apatinib mesylate is a new inhibitor of VEGFR-2 tyrosine kinase targeting the intracellular ATPbinding site of the receptor. This research needs participants satisfied following criteria: Aged between 18 and 70； Locally advanced/metastatic small lung cancer (IIIB/IV) confirmed by pathology with measurable lesions； Patients who was treated by platinum chemotherapy drugs（including sensitive recurrency and resistant recurrency） ECOG：0-2； the function of primary organs is normal. Patients voluntarily entered the study and signed informed consent form (ICF). The primary goal of this research choose ORR, DCR and adverse effects as main curative effect criteria. PFS, OS and QoL as secondary curative effect criteria.

Official Title
-----------------
Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer: A Randomized Controlled Clinical Trial

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Apatinib
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced/metastatic small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ； Patients was treated by platinum chemotherapy drugs and was diagnosed to PD； ECOG：0-2； Anticipated survival time more than 3 months； Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib； Patients voluntarily entered the study and signed informed consent form (ICF). The function in main organs of patients is normal. Exclusion Criteria: Blend cancer type with NSCLC or else； Brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms; MRI, CT or venography confirmed that tumor invaded big vessels; Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).； Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)； Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy; Urine protein≥++, or urine protein in 24 hours≥1.0g; Received big surgery, had bone fracture or ulcer in 4 weeks; Unhealed bone fracture or wound for long time; Patients with active hepatitis B virus or hepatitis C virus infection； Patients who received systemic antibiotic treatment of serious infections; Pregnant and lactational woman or patients do not receive contraception; Patients who are prone to bleed or use anticoagulant drugs. Patients who have other uncured malignant tumors. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc； Random 12 months before the artery/vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.； Known history of hypersensitivity to apatinib or any of it components.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: experimental group: Irinotecan 80mg/m2 d1,d8 vi, apatinib mesylate tablets(250mg/d) po, 4-6 cycle（21d per cycle）; controlled group: Irinotecan 80mg/m2 d1,d8 vi, 4-6 cycle（21d per cycle）;
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Patients use Apatinib Mesylate tablets combined with Irinotecan. | Drug: Apatinib<br>* Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)<br>Drug: Irinotecan<br>* Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)<br>|
| Active Comparator: controlled group<br>Patients use Irinotecan | Drug: Irinotecan<br>* Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of treatment | time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress free survival and overall survival | Secondary study endpoint | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCLC, apatinib, Irinotecan