Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Drug: Apatinib

• Registration Number: NCT03029013
• Lead Sponsor: Third Military Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Apatinib	Apatinib and chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression free survival	24 months

Secondary Outcome Measures

Name	Time	Method
overall survival	24 months

Trial Locations

Locations (1)

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China