Cervical CancerNCT03029013
Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer
A study testing Apatinib in people with Cervical Cancer, run by Third Military Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Feng Jin, M.D., 86-13908315698, wanggedaping@163.com
Ge Wang, M.D.
About this study
Official title: A Phase II Clinical Trial Study on Apatinib and Chemotherapy Sequential Treatment With Advanced Metastatic Cervical Cancer
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
- Being tested
- Apatinib
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called YN968D1
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Apatinib and chemotherapy Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 24 months
Secondary outcomes (1)
overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ge Wang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029013
- Sponsor's protocol ID
- ACSTCC
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Study on Apatinib and Chemotherapy Sequential Treatment With Advanced Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT03029013
- Acronym / sponsor ID
- ACSTCC
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: ApatinibApatinib and chemotherapy |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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：
- With written informed consent signed voluntarily by patients themselves .
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibAlso: YN968D1Apatinib， 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. | Drug | experimental group |
Primary outcome
Progression free survival
Time frame: 24 months
1 secondary outcome
overall survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apatinib in people with Cervical Cancer, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Feng, MD (86-13908315698, wanggedaping@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.