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Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

Primary Purpose

Cervical Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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;

Sites / Locations

Daping Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group

Arm Description

Apatinib and chemotherapy

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

overall survival

Full Information

NCT ID

NCT03029013

First Posted

January 19, 2017

Last Updated

January 19, 2017

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03029013

Brief Title

Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

Apatinib and chemotherapy

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

YN968D1

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

24 months

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Feng, MD

Phone

86-13908315698

wanggedaping@163.com

Facility Information:

Facility Name

Daping Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Feng Jin, M.D.

Phone

86-13908315698

wanggedaping@163.com

First Name & Middle Initial & Last Name & Degree

Ge Wang, M.D.

First Name & Middle Initial & Last Name & Degree

Feng Jin, M.D.

12. IPD Sharing Statement

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Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

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