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Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Ge Wang, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT03029013
First received: January 19, 2017
Last updated: NA
Last verified: January 2017
History: No changes posted
  Purpose
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

Condition Intervention
Cervical Cancer
Drug: Apatinib

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Study on Apatinib and Chemotherapy Sequential Treatment With Advanced Metastatic Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 24 months ]

Estimated Enrollment: 30
Study Start Date: January 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental group
Apatinib and chemotherapy
Drug: Apatinib
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.
Other Name: YN968D1

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03029013

Contacts
Contact: Jin Feng, MD 86-13908315698 wanggedaping@163.com

Locations
China, Chongqing
Daping Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Feng Jin, M.D.    86-13908315698    wanggedaping@163.com   
Principal Investigator: Ge Wang, M.D.         
Principal Investigator: Feng Jin, M.D.         
Sponsors and Collaborators
Third Military Medical University
  More Information

Responsible Party: Ge Wang, M.D., Third Military Medical University
ClinicalTrials.gov Identifier: NCT03029013     History of Changes
Other Study ID Numbers: ACSTCC 
Study First Received: January 19, 2017
Last Updated: January 19, 2017

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on January 23, 2017