NCT03029013

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

2.9 years

First QC Date

January 19, 2017

Last Update Submit

January 19, 2017

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    24 months

Secondary Outcomes (1)

  • overall survival

    24 months

Study Arms (1)

experimental group

EXPERIMENTAL

Apatinib and chemotherapy

Drug: Apatinib

Interventions

ApatinibDRUG

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.

Also known as: YN968D1
experimental group

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Jin Feng, MD

CONTACT

86-13908315698wanggedaping@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 23, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

CN(1)