Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

Third Military Medical University

Status

Unknown

Conditions

Cervical Cancer

Treatments

Drug: Apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03029013

ACSTCC

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

Female

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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;