Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

Study Overview
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Brief Summary
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The study is the single arm and single center clinical trials，We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy sequential treatment with advanced recurrence of metastatic cervical cancer

Official Title
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A Phase II Clinical Trial Study on Apatinib and Chemotherapy Sequential Treatment With Advanced Metastatic Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The pathological diagnosis of recurrent or metastatic cervical cancer; Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1; Life expectancy of more than 3months; With normal marrow, liver and renal function： blood routine examination ：HB≥90g/L，ANC ≥1.5×10*9/L，PLT≥80×10*9/L； Biochemical examination: total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL)，alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of ≤2.5 UNL or ≤5 UNL ，acreatinine (Cr) of ≤ 1.25 UNL; creatinine clearance rate ≥ 45ml/min (Cockcroft-Gault); With written informed consent signed voluntarily by patients themselves . With good compliance and agree to accept follow-up of disease progression and adverse events. Exclusion Criteria: Uncontrolled hypertension Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias With abnormal coagulation function， bleeding tendency or treating with thrombolysis and anticoagulation History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization; uncured the wound or fracture Centrally located tumors of local invasion of major blood vessels, or Researchers think that patients may invade the important blood vessels and cause fatal bleeding (CT or MRI); Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction); Urine protein >++, or urine protein in 24 hours> 1.0g Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment History of uncontrolled psychotropic drug abuse or mental disorders; Prior VEGFR inhibitor treatment ; Other malignancy within Before or at the same time other than basal cell skin cancer, or carcinoma in situ of the cervix;

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Apatinib and chemotherapy | Drug: Apatinib<br>* Apatinib， 250 mg qd，po，after 7 days , paclitaxel (135-175 mg/m2) and platinum two drug standard chemotherapy, 21 days as a treatment cycle，during the chemotherapy of 7-21 days continue to offer the Apatinib. without disease progress, after 4 chemotherapy cycles, patients continue to accept the Apatinib maintenance treatment.<br>* Other names: YN968D1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 24 months |