Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

NCT ID: NCT03029013

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-12-31

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

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Apatinib and chemotherapy

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

YN968D1

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;

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ge Wang

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jin Feng, MD

Role: CONTACT

wanggedaping@163.com

86-13908315698

Facility Contacts

Feng Jin, M.D.

Role: primary

wanggedaping@163.com

86-13908315698

Other Identifiers

ACSTCC

Identifier Type: -

Identifier Source: org_study_id